modality directory

monoclonal antibody clinical trial intelligence

Trials are included when the normalized modality field matches this therapeutic modality. Full protocol, result, eligibility and IP analysis is available inside the premium workspace.

Validated reports

100

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modality

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normalized field

NCT05308446
Source recordAI-normalized

Randomized Phase II Trial of Encorafenib and Cetuximab With or Without Nivolumab (NSC #748726) for Patients With Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer

This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.

AI analysis

Indication: Metastatic Colon Adenocarcinoma

Modality: monoclonal antibody

Target: Cetuximab, Encorafenib, Nivolumab

Sponsor: National Cancer Institute (NCI)

Source URL: ClinicalTrials.gov

Source updated: Jun 03, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

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Condition raw: Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Unresectable Colon Adenocarcinoma, Unresectable Rectal Adenocarcinoma

Condition normalized: Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Unresectable Colon Adenocarcinoma, Unresectable Rectal Adenocarcinoma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Cetuximab, Encorafenib, Nivolumab

Target normalized: Cetuximab, Encorafenib, Nivolumab

Open report
NCT01200758
Source recordAI-normalized

A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.

AI analysis

Indication: Non-Hodgkin's Lymphoma

Modality: monoclonal antibody

Target: Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Nov 27, 2018

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Non-Hodgkin's Lymphoma

Condition normalized: Non-Hodgkin's Lymphoma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone

Target normalized: Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone

Open report
NCT00107380
Source recordAI-normalized

Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving iodine I 131 tositumomab together with rituximab and combination chemotherapy works in treating older patients with stage II, stage III, or stage IV B-cell non-Hodgkin's lymphoma.

AI analysis

Indication: Lymphoma

Modality: monoclonal antibody

Target: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, tositumomab and iodine I 131 tositumomab

Sponsor: SWOG Cancer Research Network

Source URL: ClinicalTrials.gov

Source updated: Mar 07, 2016

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Lymphoma

Condition normalized: Lymphoma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, tositumomab and iodine I 131 tositumomab

Target normalized: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, tositumomab and iodine I 131 tositumomab

Open report
NCT06191744
Source recordAI-normalized

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

AI analysis

Indication: Follicular Lymphoma (FL)

Modality: monoclonal antibody

Target: Epcoritamab, Prednisone, Rituximab, Lenalidomide, Doxorubicin, Vincristine, Cyclophosphamide, Obinutuzumab, Bendamustine

Sponsor: Genmab

Source URL: ClinicalTrials.gov

Source updated: Jun 02, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Follicular Lymphoma (FL)

Condition normalized: Follicular Lymphoma (FL)

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Epcoritamab, Prednisone, Rituximab, Lenalidomide, Doxorubicin, Vincristine, Cyclophosphamide, Obinutuzumab, Bendamustine

Target normalized: Epcoritamab, Prednisone, Rituximab, Lenalidomide, Doxorubicin, Vincristine, Cyclophosphamide, Obinutuzumab, Bendamustine

Open report
NCT00070447
Source recordAI-normalized

Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma

RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma.

AI analysis

Indication: Lymphoma

Modality: monoclonal antibody

Target: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, yttrium Y 90 ibritumomab tiuxetan

Sponsor: National Cancer Institute (NCI)

Source URL: ClinicalTrials.gov

Source updated: Jan 28, 2014

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Lymphoma

Condition normalized: Lymphoma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, yttrium Y 90 ibritumomab tiuxetan

Target normalized: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, yttrium Y 90 ibritumomab tiuxetan

Open report
NCT00544219
Source recordAI-normalized

Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study

RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin, vincristine, and prednisone.

AI analysis

Indication: Lymphoma

Modality: monoclonal antibody

Target: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, positron emission tomography

Sponsor: Swiss Cancer Institute

Source URL: ClinicalTrials.gov

Source updated: May 15, 2019

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Lymphoma

Condition normalized: Lymphoma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, positron emission tomography

Target normalized: rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate, positron emission tomography

Open report
NCT03677141
Source recordAI-normalized

A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).

AI analysis

Indication: B-cell Non-Hodgkin Lymphoma

Modality: monoclonal antibody

Target: Mosunetuzumab, Polatuzumab Vedotin, Rituxumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Tocilizumab

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Dec 18, 2024

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: B-cell Non-Hodgkin Lymphoma

Condition normalized: B-cell Non-Hodgkin Lymphoma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Mosunetuzumab, Polatuzumab Vedotin, Rituxumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Tocilizumab

Target normalized: Mosunetuzumab, Polatuzumab Vedotin, Rituxumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Tocilizumab

Open report
NCT06095427
Source recordAI-normalized

A Randomized, Double Blind, Three-Arm, Parallel Group, Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US Prolia and EU Prolia by Single-Dose Subcutaneous Injection

This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics (PD) between the test product L06006 and the reference products US-Prolia and EU-Prolia in healthy male subjects. A total of 300 healthy male subjects aged 28 to 65 years (both inclusive) will be randomized 1:1:1 to receive a single subcutaneous (s.c.) injection of either LY06006 or US-Prolia or EU-Prolia on Day 1 and then be followed for 36 weeks.

AI analysis

Indication: Healthy

Modality: monoclonal antibody

Target: LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Sponsor: Luye Pharma Group Ltd.

Source URL: ClinicalTrials.gov

Source updated: Oct 23, 2023

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Healthy

Condition normalized: Healthy

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Target normalized: LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia

Open report
NCT03839459
Source recordAI-normalized

Denosumab for Smoldering Multiple Myeloma

This study will assess the safety and tolerability of denosumab in smoldering multiple myeloma subjects as well to see if denosumab can reduce subjects' risk of getting multiple myeloma.

AI analysis

Indication: Smoldering Multiple Myeloma

Modality: monoclonal antibody

Target: Denosumab

Sponsor: University of Rochester

Source URL: ClinicalTrials.gov

Source updated: Jan 28, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Smoldering Multiple Myeloma

Condition normalized: Smoldering Multiple Myeloma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report
NCT01575873
Source recordAI-normalized

A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

AI analysis

Indication: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Modality: monoclonal antibody

Target: Denosumab, Placebo for risendronate, Risendronate, Placebo for denosumab

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Jul 27, 2018

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Condition normalized: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab, Placebo for risendronate, Risendronate, Placebo for denosumab

Target normalized: Denosumab, Placebo for risendronate, Risendronate, Placebo for denosumab

Open report
NCT02053753
Source recordAI-normalized

A Double-Blind, Randomized, Single-Dose, Parallel-Group Study in Healthy Volunteers to Assess the Bioequivalence of a 120 mg Denosumab Subcutaneous Dose When Administered as Denosumab CP4 Drug Product or as Commercially Available Denosumab CP2 Drug Product

To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.

AI analysis

Indication: Healthy Volunteer

Modality: monoclonal antibody

Target: Denosumab CP4, Denosumab CP2

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Dec 29, 2017

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Healthy Volunteer

Condition normalized: Healthy Volunteer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab CP4, Denosumab CP2

Target normalized: Denosumab CP4, Denosumab CP2

Open report
NCT05419050
Source recordAI-normalized

A Phase 2 Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia

Background: Fibrous dysplasia (FD) is a disease that affects the bones. It causes bone lesions that can become weak and lead to fractures, deformity, and nerve injuries. FD bone lesions begin to develop soon after birth and grow during childhood. The lesions stop growing in adults but can still cause disability. Researchers want to find ways to stop the growth of FD bone lesions. Objective: To test a study drug (denosumab) in children with FD. Eligibility: Children aged 4 to 14 years with FD and who are also enrolled in the Screening and Natural History protocol (98-D-0145). Design: Participants will have a screening visit at the NIH clinic or by telehealth. Their medical history will be reviewed. Participants will stay overnight in the hospital 4 times in 76 weeks. Each stay will last 5 to 7 nights. Participants will also visit a local lab for blood and urine tests every 4 weeks during the study. Participants will receive denosumab once every 4 weeks for 48 weeks. The medication is given as a shot injected under the skin using a small needle. Some injections may be performed at home by a caregiver. The caregiver will receive training for this procedure. Participants will undergo many tests that may be repeated throughout the study. They will have a dental exam. They will have tests of their strength and ability to move freely. They will have x-rays and other scans to get pictures of their bones. Participants will be given another medicine that is administered through a needle in the arm over 30 minutes.

AI analysis

Indication: Fibrous Dysplasia

Modality: monoclonal antibody

Target: denosumab

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Source URL: ClinicalTrials.gov

Source updated: Jan 20, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Fibrous Dysplasia

Condition normalized: Fibrous Dysplasia

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: denosumab

Target normalized: denosumab

Open report
NCT04608630
Source recordAI-normalized

Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults - A Randomised Controlled Trial

The Bone Zone trial is a prospective, multi-centre, double-blind, phase II, randomised controlled trial evaluating the effect of denosumab or zoledronic acid compared to placebo on change in bone mineral density over one year in women aged 50 years or older and men aged 70 years or older requiring admission to intensive care for greater than 24 hours. 450 women aged 50 years or older and men aged 70 years or older, admitted to intensive care for greater than 24 hours will be recruited into the study from participating study centres.

AI analysis

Indication: Critical Illness

Modality: monoclonal antibody

Target: Denosumab 60 MG/ML, Zoledronic Acid 5Mg/Bag 100Ml Inj, Sodium Chloride 0.9% or 5% Dextrose Intravenous, Sodium Chloride 0.9% Injection

Sponsor: Australian and New Zealand Intensive Care Research Centre

Source URL: ClinicalTrials.gov

Source updated: Mar 04, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Critical Illness, Osteoporosis

Condition normalized: Critical Illness, Osteoporosis

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab 60 MG/ML, Zoledronic Acid 5Mg/Bag 100Ml Inj, Sodium Chloride 0.9% or 5% Dextrose Intravenous, Sodium Chloride 0.9% Injection

Target normalized: Denosumab 60 MG/ML, Zoledronic Acid 5Mg/Bag 100Ml Inj, Sodium Chloride 0.9% or 5% Dextrose Intravenous, Sodium Chloride 0.9% Injection

Open report
NCT01464931
Source recordAI-normalized

An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis

AI analysis

Indication: Renal Impairment

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Feb 19, 2016

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Renal Impairment

Condition normalized: Renal Impairment

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report
NCT06361355
Source recordAI-normalized

A Randomized, Double-blind, Parallel Controlled, Phase I Study, Comparing the PK, PD, Safety, and Immunogenicity of Post-change CMAB807and Prolia in Healthy Chinese Subjects

This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose

AI analysis

Indication: Healthy Volunteers

Modality: monoclonal antibody

Target: Post-change CMAB807, Prolia

Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

Source URL: ClinicalTrials.gov

Source updated: Nov 07, 2024

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Healthy Volunteers

Condition normalized: Healthy Volunteers

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Post-change CMAB807, Prolia

Target normalized: Post-change CMAB807, Prolia

Open report
NCT05777109
Source recordAI-normalized

A Dual-center, Randomized, Double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, Pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults

A Dual-center , Randomized, double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults

AI analysis

Indication: Healthy

Modality: monoclonal antibody

Target: HS-20090, Xgeva®

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Source URL: ClinicalTrials.gov

Source updated: Aug 23, 2023

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Healthy

Condition normalized: Healthy

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: HS-20090, Xgeva®

Target normalized: HS-20090, Xgeva®

Open report
NCT03005678
Source recordAI-normalized

Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial

A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: Denosumab, Alendronate

Sponsor: Tuen Mun Hospital

Source URL: ClinicalTrials.gov

Source updated: Feb 12, 2020

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis

Condition normalized: Osteoporosis

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab, Alendronate

Target normalized: Denosumab, Alendronate

Open report
NCT05010590
Source recordAI-normalized

Anabolic Therapy in Postmenopausal Osteoporosis

In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.

AI analysis

Indication: Postmenopausal Osteoporosis

Modality: monoclonal antibody

Target: Romosozumab, Denosumab

Sponsor: Massachusetts General Hospital

Source URL: ClinicalTrials.gov

Source updated: Apr 15, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Postmenopausal Osteoporosis

Condition normalized: Postmenopausal Osteoporosis

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Romosozumab, Denosumab

Target normalized: Romosozumab, Denosumab

Open report
NCT01358669
Source recordAI-normalized

Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip

Although hip replacement surgery is a successful way of dealing with the pain and immobility caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10 years. The main reason for this is the development periprosthetic osteolysis, that is, loss of bone around the site of the hip replacement. The osteolysis is thought to be due to the small particles of debris worn from the surfaces of the hip implant. These particles cause a reaction in the blood cells around the joint which in turn affects bone cells and leads to a loss of bone around the implant. The joint implant will then eventually become loose and unstable, a condition known as aseptic loosening. At present the only way to treat aseptic loosening is to have another operation to secure the hip joint, known as revision surgery. Revision surgery is not always successful and exposes the patient to the risk of major surgery. In this study we explore the potential for giving a medication (denosumab) that may prevent the loss of bone around the hip replacement implant. We will recruit patients who have been listed for revision surgery. One group of patients will be given a single dose of denosumab; another group will be given a placebo (dummy drug). At the time of the revision surgery a small sample of the bone from around the hip replacement will be taken and examined under the microscope. Comparisons will be made between the patients having the denosumab and those having placebo to find out whether the denosumab is having a beneficial effect on the bone surfaces. If successful, this study will lead to further studies to develop the use of denosumab to prevent aseptic loosening.

AI analysis

Indication: Revision Surgery of Total Hip Arthroplasty

Modality: monoclonal antibody

Target: Denosumab, Placebo

Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Source URL: ClinicalTrials.gov

Source updated: Aug 29, 2022

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Revision Surgery of Total Hip Arthroplasty

Condition normalized: Revision Surgery of Total Hip Arthroplasty

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab, Placebo

Target normalized: Denosumab, Placebo

Open report
NCT02049866
Source recordAI-normalized

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)

The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis. Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months). The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women. Funding Source: FDA Office of Orphan Products Development (OOPD).

AI analysis

Indication: Adult Idiopathic Generalized Osteoporosis

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Elizabeth Shane

Source URL: ClinicalTrials.gov

Source updated: Dec 12, 2022

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Adult Idiopathic Generalized Osteoporosis

Condition normalized: Adult Idiopathic Generalized Osteoporosis

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report
NCT00321620
Source recordAI-normalized

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

AI analysis

Indication: Bone Metastases

Modality: monoclonal antibody

Target: zoledronic acid, denosumab

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Aug 29, 2018

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Bone Metastases

Condition normalized: Bone Metastases

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: zoledronic acid, denosumab

Target normalized: zoledronic acid, denosumab

Open report
NCT00286091
Source recordAI-normalized

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer

The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.

AI analysis

Indication: Hormone Refractory Prostate Cancer

Modality: monoclonal antibody

Target: Denosumab, Placebo

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Oct 17, 2018

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Hormone Refractory Prostate Cancer

Condition normalized: Hormone Refractory Prostate Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab, Placebo

Target normalized: Denosumab, Placebo

Open report
NCT02352753
Source recordAI-normalized

To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.

AI analysis

Indication: Osteogenesis Imperfecta

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Dec 28, 2022

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteogenesis Imperfecta

Condition normalized: Osteogenesis Imperfecta

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report
NCT05125809
Source recordAI-normalized

An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta

The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.

AI analysis

Indication: Osteogenesis Imperfecta

Modality: monoclonal antibody

Target: Setrusumab, Placebo

Sponsor: Ultragenyx Pharmaceutical Inc

Source URL: ClinicalTrials.gov

Source updated: Feb 25, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteogenesis Imperfecta

Condition normalized: Osteogenesis Imperfecta

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Setrusumab, Placebo

Target normalized: Setrusumab, Placebo

Open report
NCT04545554
Source recordAI-normalized

An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).

AI analysis

Indication: Osteogenesis Imperfecta

Modality: monoclonal antibody

Target: Romosozumab, Calcium, Vitamin D

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Apr 15, 2024

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteogenesis Imperfecta

Condition normalized: Osteogenesis Imperfecta

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Romosozumab, Calcium, Vitamin D

Target normalized: Romosozumab, Calcium, Vitamin D

Open report
NCT05312697
Source recordAI-normalized

A Phase 2b, Multicenter, Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta

The primary objective of the study is to evaluate bone mineral density (BMD) after 12 months of retreatment with monthly setrusumab in adults with osteogenesis imperfecta (OI).

AI analysis

Indication: Osteogenesis Imperfecta

Modality: monoclonal antibody

Target: Setrusumab

Sponsor: Ultragenyx Pharmaceutical Inc

Source URL: ClinicalTrials.gov

Source updated: Jul 23, 2025

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteogenesis Imperfecta

Condition normalized: Osteogenesis Imperfecta

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Setrusumab

Target normalized: Setrusumab

Open report
NCT06508658
Source recordAI-normalized

A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 360 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world. Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants in arm B will receive intravenously (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days). Participants in arm C will receive SC injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

AI analysis

Indication: Diffuse Large B-Cell Lymphoma

Modality: monoclonal antibody

Target: Epcoritamab, Rituximab, Lenalidomide, Oxaliplatin, Gemcitabine

Sponsor: Genmab

Source URL: ClinicalTrials.gov

Source updated: Apr 08, 2026

Ingested: Jun 11, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Diffuse Large B-Cell Lymphoma

Condition normalized: Diffuse Large B-Cell Lymphoma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Epcoritamab, Rituximab, Lenalidomide, Oxaliplatin, Gemcitabine

Target normalized: Epcoritamab, Rituximab, Lenalidomide, Oxaliplatin, Gemcitabine

Open report
NCT00576758
Source recordAI-normalized

An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma

This study will investigate the efficacy of weekly intravenous obinutuzumab \[GA101 (RO5072759)\] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.

AI analysis

Indication: Non-Hodgkin's Lymphoma

Modality: monoclonal antibody

Target: obinutuzumab (RO5072759), rituximab

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Aug 19, 2014

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Non-Hodgkin's Lymphoma

Condition normalized: Non-Hodgkin's Lymphoma

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: obinutuzumab (RO5072759), rituximab

Target normalized: obinutuzumab (RO5072759), rituximab

Open report
NCT04324021
Source recordAI-normalized

A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection.

Hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system in the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is considered to represent one of the most important negative prognostic factors in patients infected with sSARS-CoV-2. The objective of this study is to investigate new treatment options to reduce the number of patients requiring mechanical ventilation. This is intended to address the most urgent need to preserve the access to intensive care unit support to the lowest possible number of patients and may potentially reduce mortality.

AI analysis

Indication: SARS-CoV-2

Modality: monoclonal antibody

Target: Emapalumab, Anakinra

Sponsor: Swedish Orphan Biovitrum

Source URL: ClinicalTrials.gov

Source updated: Mar 10, 2022

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: SARS-CoV-2

Condition normalized: SARS-CoV-2

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Emapalumab, Anakinra

Target normalized: Emapalumab, Anakinra

Open report
NCT04900428
Source recordAI-normalized

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19

This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.

AI analysis

Indication: Covid19

Modality: monoclonal antibody

Target: COVI-DROPS, Placebo

Sponsor: Sorrento Therapeutics, Inc.

Source URL: ClinicalTrials.gov

Source updated: Jan 30, 2023

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Covid19

Condition normalized: Covid19

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: COVI-DROPS, Placebo

Target normalized: COVI-DROPS, Placebo

Open report
NCT04738175
Source recordAI-normalized

A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.

AI analysis

Indication: Covid19

Modality: monoclonal antibody

Target: COVI-AMG, Placebo

Sponsor: Sorrento Therapeutics, Inc.

Source URL: ClinicalTrials.gov

Source updated: Feb 25, 2022

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Covid19

Condition normalized: Covid19

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: COVI-AMG, Placebo

Target normalized: COVI-AMG, Placebo

Open report
NCT03464136
Source recordAI-normalized

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

AI analysis

Indication: Crohn Disease

Modality: monoclonal antibody

Target: Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Sponsor: Janssen Scientific Affairs, LLC

Source URL: ClinicalTrials.gov

Source updated: Apr 29, 2025

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Crohn Disease

Condition normalized: Crohn Disease

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Target normalized: Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Open report
NCT04454398
Source recordAI-normalized

A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-1499 (COVI-GUARD™) in Hospitalized Patients With Moderate COVID-19

Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19

AI analysis

Indication: Covid-19

Modality: monoclonal antibody

Target: COVI-GUARD, Standard of Care, Placebo

Sponsor: Sorrento Therapeutics, Inc.

Source URL: ClinicalTrials.gov

Source updated: Jan 08, 2021

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Covid-19

Condition normalized: Covid-19

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: COVI-GUARD, Standard of Care, Placebo

Target normalized: COVI-GUARD, Standard of Care, Placebo

Open report
NCT07246863
Source recordAI-normalized

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)

This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

AI analysis

Indication: Metastatic Non-Squamous Non-Small Cell Lung Cancer

Modality: monoclonal antibody

Target: Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel

Sponsor: CatalYm GmbH

Source URL: ClinicalTrials.gov

Source updated: Jun 09, 2026

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor

Condition normalized: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel

Target normalized: Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel

Open report
NCT03312907
Source recordAI-normalized

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.

AI analysis

Indication: Systemic Lupus Erythematosus

Modality: monoclonal antibody

Target: Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Sponsor: GlaxoSmithKline

Source URL: ClinicalTrials.gov

Source updated: Feb 18, 2025

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Systemic Lupus Erythematosus

Condition normalized: Systemic Lupus Erythematosus

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Target normalized: Belimumab, Rituximab, Rituximab-placebo, Standard therapy (Including Immunosuppressants), Standard therapy (Excluding Immunosuppressants), Steroid Taper

Open report
NCT04840758
Source recordAI-normalized

A Prospective Single-arm Single-center Clinical Study:Assessment of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) Combined With Sintilimab in Early Inoperable Synchronous Multiple Primary Lung Cancer (sMPLC)

The purpose of this study is to assess of the Safety and Effects of Stereotactic Ablation Radiotherapy (SABR) combined with Sintilimab in early inoperable synchronous Multiple Primary Lung Cancer (sMPLC)

AI analysis

Indication: Multiple Primary Lung Cancer

Modality: monoclonal antibody

Target: Stereotactic Ablation Radiotherapy, Sintilimab

Sponsor: The First Affiliated Hospital of Xiamen University

Source URL: ClinicalTrials.gov

Source updated: Apr 12, 2021

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Multiple Primary Lung Cancer

Condition normalized: Multiple Primary Lung Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Stereotactic Ablation Radiotherapy, Sintilimab

Target normalized: Stereotactic Ablation Radiotherapy, Sintilimab

Open report
NCT03761914
Source recordAI-normalized

A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers

To evaluate the safety, tolerability, and anti-tumor activity of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers.

AI analysis

Indication: Acute Myelogenous Leukemia

Modality: monoclonal antibody

Target: galinpepimut-S, pembrolizumab, Montanide, GM-CSF

Sponsor: Sellas Life Sciences Group

Source URL: ClinicalTrials.gov

Source updated: Nov 19, 2024

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Acute Myelogenous Leukemia, Ovarian Cancer, Colorectal Cancer, Triple-negative Breast Cancer, Small-cell Lung Cancer

Condition normalized: Acute Myelogenous Leukemia, Ovarian Cancer, Colorectal Cancer, Triple-negative Breast Cancer, Small-cell Lung Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: galinpepimut-S, pembrolizumab, Montanide, GM-CSF

Target normalized: galinpepimut-S, pembrolizumab, Montanide, GM-CSF

Open report
NCT02481830
Source recordAI-normalized

An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)

The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

AI analysis

Indication: Lung Cancer

Modality: monoclonal antibody

Target: Nivolumab, Topotecan, Amrubicin

Sponsor: Bristol-Myers Squibb

Source URL: ClinicalTrials.gov

Source updated: Jul 27, 2023

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Lung Cancer

Condition normalized: Lung Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Nivolumab, Topotecan, Amrubicin

Target normalized: Nivolumab, Topotecan, Amrubicin

Open report
NCT03487263
Source recordAI-normalized

A Phase 1b, Open-Label, Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease

Ten patients with motor neurone disease (MND, also known as amyotrophic lateral sclerosis or ALS) will be successively enrolled to one of two dose levels of IC14 (human chimeric monoclonal anti-CD14) intravenously for four doses. Patients must be within 3 years of MND diagnosis and have adequate respiratory function. Safety, tolerability, immunogenicity, and PK/PD will be measured. To evaluate feasibility of the endpoints, additional endpoints of ALSFRS-R, respiratory function tests, disease biomarkers and patient-reported outcomes will be measured.

AI analysis

Indication: Motor Neuron Disease

Modality: monoclonal antibody

Target: IC14

Sponsor: Implicit Bioscience

Source URL: ClinicalTrials.gov

Source updated: Aug 20, 2025

Ingested: Jun 09, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Condition normalized: Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: IC14

Target normalized: IC14

Open report
NCT04675827
Source recordAI-normalized

De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade

DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator's discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator's discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).

AI analysis

Indication: HER2-positive Breast Cancer

Modality: monoclonal antibody

Target: Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine

Sponsor: Jules Bordet Institute

Source URL: ClinicalTrials.gov

Source updated: Dec 04, 2024

Ingested: Jun 08, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, Node-negative Breast Cancer

Condition normalized: HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, Node-negative Breast Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine

Target normalized: Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine

Open report
NCT03529110
Source recordAI-normalized

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Sponsor: Daiichi Sankyo

Source URL: ClinicalTrials.gov

Source updated: Oct 21, 2025

Ingested: Jun 08, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer

Condition normalized: Breast Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Target normalized: Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)

Open report
NCT01196052
Source recordAI-normalized

A Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Cancer

This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: Trastuzumab emtansine

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Oct 06, 2014

Ingested: Jun 08, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer

Condition normalized: Breast Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Trastuzumab emtansine

Target normalized: Trastuzumab emtansine

Open report
NCT04620187
Source recordAI-normalized

A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas

This clinical trial, sponsored by Dana-Farber Cancer Institute in collaboration with Genentech, investigates the safety and efficacy of Ado-trastuzumab emtansine (T-DM1) combined with standard chemoradiation in patients with HER2-positive salivary gland cancer. The trial aims to establish a treatment protocol for a cancer type lacking FDA-approved therapies.

AI analysis

Indication: Salivary Gland Cancer

Modality: monoclonal antibody

Target: HER2-positive Salivary Gland Carcinomas

Sponsor: Dana-Farber Cancer Institute

Source URL: ClinicalTrials.gov

Source updated: Apr 13, 2026

Ingested: Jun 05, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Salivary Gland Cancer, HER2 Gene Mutation

Condition normalized: Salivary Gland Cancer, HER2 Gene Mutation

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Ado-trastuzumab (T) emtansine (T-DM1), Standard of Care Radiotherapy, Standard of Care Chemotherapy

Target normalized: HER2-positive Salivary Gland Carcinomas

Open report
NCT02658734
Source recordAI-normalized

A Multicenter, Open-Label, Single-Arm, Phase IV Study of Trastuzumab Emtansine in Indian Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane

This study evaluated the safety of trastuzumab emtansine in Indian patients with HER2-positive breast cancer who had prior treatment with trastuzumab and a taxane. Conducted by Hoffmann-La Roche, it involved 70 participants across 13 centers in India.

AI analysis

Indication: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

Modality: monoclonal antibody

Target: HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Apr 02, 2021

Ingested: Jun 05, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

Condition normalized: HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Trastuzumab emtansine

Target normalized: HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Open report
NCT01772472
Source recordAI-normalized

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: trastuzumab, trastuzumab emtansine

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Jul 22, 2025

Ingested: Jun 05, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer

Condition normalized: Breast Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: trastuzumab, trastuzumab emtansine

Target normalized: trastuzumab, trastuzumab emtansine

Open report
NCT01835236
Source recordAI-normalized

A Randomized Phase II Trial of Pertuzumab in Combination With Trastuzumab With or Without Chemotherapy, Both Followed by T-DM1 in Case of Progression, in Patients With HER2-positive Metastatic Breast Cancer

This clinical trial evaluates a novel treatment strategy for HER2-positive metastatic breast cancer, comparing a chemotherapy-free regimen of trastuzumab and pertuzumab followed by T-DM1 against a chemotherapy-inclusive regimen. The study aims to determine if the new strategy offers similar or improved efficacy and tolerability compared to standard treatments.

AI analysis

Indication: Metastatic Breast Cancer

Modality: monoclonal antibody

Target: HER2-positive Metastatic Breast Cancer

Sponsor: Swiss Cancer Institute

Source URL: ClinicalTrials.gov

Source updated: Mar 30, 2021

Ingested: Jun 05, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Metastatic Breast Cancer

Condition normalized: Metastatic Breast Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Trastuzumab, Pertuzumab, Paclitaxel, Vinorelbine, T-DM1

Target normalized: HER2-positive Metastatic Breast Cancer

Open report
NCT02144012
Source recordAI-normalized

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel as First-Line Treatment of Patients With Her2-Positive Progressive Or Recurrent Locally Advanced Or Metastatic Breast Cancer.

This terminated clinical trial aimed to evaluate the efficacy and safety of trastuzumab emtansine compared to trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer. The study enrolled only 49 participants out of the planned 561, leading to its termination.

AI analysis

Indication: Metastatic Breast Cancer

Modality: monoclonal antibody

Target: HER2-positive Breast Cancer

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Mar 07, 2017

Ingested: Jun 05, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Metastatic Breast Cancer

Condition normalized: Metastatic Breast Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Trastuzumab, Trastuzumab Emtansine, Docetaxel

Target normalized: HER2-positive Breast Cancer

Open report
NCT00321464
Source recordAI-normalized

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer

This clinical trial, sponsored by Amgen and in collaboration with Daiichi Sankyo, aimed to compare the efficacy of Denosumab against Zoledronic Acid in treating bone metastases in patients with advanced breast cancer. The study enrolled 2049 participants and was completed in April 2012.

AI analysis

Indication: Bone Metastases

Modality: monoclonal antibody

Target: Denosumab, Zoledronic Acid

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Nov 08, 2022

Ingested: Jun 04, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Bone Metastases

Condition normalized: Bone Metastases

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab, Zoledronic Acid

Target normalized: Denosumab, Zoledronic Acid

Open report
NCT03755193
Source recordAI-normalized

Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

This clinical trial, sponsored by Shinshu University, aims to evaluate the efficacy and safety of different anti-resorption drugs (SERM and bisphosphonates) following a 2-year denosumab therapy in Japanese osteoporosis patients. The study is currently recruiting participants and is expected to complete by November 2026.

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug", ELD "Edirol®Tablet 0.75ug"

Sponsor: Shinshu University

Source URL: ClinicalTrials.gov

Source updated: Sep 21, 2021

Ingested: Jun 04, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis

Condition normalized: Osteoporosis

Modality raw: small molecule

Modality normalized: monoclonal antibody

Target raw: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug", ELD "Edirol®Tablet 0.75ug"

Target normalized: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug", ELD "Edirol®Tablet 0.75ug"

Open report
NCT02721433
Source recordAI-normalized

A Pragmatic Randomised, Multicentre Trial Comparing 4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases From Either Castration-resistant Prostate Cancer or Breast Cancer - The REaCT-BTA Study

The REaCT-BTA study evaluates the efficacy of 4-weekly versus 12-weekly administration of bone-targeted agents (BTAs) in improving quality of life and reducing skeletal-related events in patients with bone metastases from castration-resistant prostate cancer or breast cancer. The trial was conducted by the Ottawa Hospital Research Institute and completed in April 2020 with 263 enrolled participants.

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: Pamidronate, Denosumab, Zoledronate

Sponsor: Ottawa Hospital Research Institute

Source URL: ClinicalTrials.gov

Source updated: Dec 02, 2020

Ingested: Jun 04, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer, Prostate Cancer, Metastasis

Condition normalized: Breast Cancer, Prostate Cancer, Metastasis

Modality raw: small molecule

Modality normalized: monoclonal antibody

Target raw: Pamidronate, Denosumab, Zoledronate

Target normalized: Pamidronate, Denosumab, Zoledronate

Open report
NCT06414616
Source recordAI-normalized

Are We Overly Concerned About Rebound Fractures? Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal: A Cross-sectional Study

This study investigates the adherence to Denosumab therapy and the associated fracture risk upon discontinuation, particularly during the COVID-19 pandemic. It aims to provide real-world evidence on the implications of treatment compliance and the potential rebound effect on fracture risk in osteoporosis patients.

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: Osteoporosis

Sponsor: Trakya University

Source URL: ClinicalTrials.gov

Source updated: May 16, 2024

Ingested: Jun 04, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis

Condition normalized: Osteoporosis

Modality raw: Detailed source ingestion pending

Modality normalized: monoclonal antibody

Target raw: Osteoporosis

Target normalized: Osteoporosis

Open report
NCT04729621
Source recordAI-normalized

A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia®) in Patients With Postmenopausal Osteoporosis

Teva Pharmaceuticals USA conducted a Phase 3 clinical trial (NCT04729621) to evaluate the efficacy and safety of TVB-009P compared to Denosumab (Prolia®) in treating postmenopausal osteoporosis. The study involved 332 participants and was completed in June 2023.

AI analysis

Indication: Osteoporosis, Postmenopausal

Modality: monoclonal antibody

Target: TVB-009, Prolia®

Sponsor: Teva Pharmaceuticals USA

Source URL: ClinicalTrials.gov

Source updated: Apr 18, 2024

Ingested: Jun 04, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis, Postmenopausal

Condition normalized: Osteoporosis, Postmenopausal

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: TVB-009, Prolia®

Target normalized: TVB-009, Prolia®

Open report
NCT03651947
Source recordAI-normalized

A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults

QL1206 is being developed by Qilu Pharmaceutical Co., Ltd. as a biosimilar to Xgeva® (Denosumab), targeting the treatment of conditions related to bone metabolism. The trial aimed to establish pharmacokinetic, safety, and pharmacodynamic similarities between QL1206 and Xgeva® in healthy adults.

AI analysis

Indication: Healthy People

Modality: monoclonal antibody

Target: QL1206, Xgeva®

Sponsor: Qilu Pharmaceutical Co., Ltd.

Source URL: ClinicalTrials.gov

Source updated: Oct 16, 2019

Ingested: Jun 04, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Healthy People

Condition normalized: Healthy People

Modality raw: small molecule

Modality normalized: monoclonal antibody

Target raw: QL1206, Xgeva®

Target normalized: QL1206, Xgeva®

Open report
NCT05395091
Source recordAI-normalized

A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND

The ALVOBOND study evaluates AVT03, a proposed biosimilar to Prolia (denosumab), in postmenopausal women with osteoporosis. The trial aims to demonstrate comparable efficacy, safety, immunogenicity, and pharmacokinetic profiles between AVT03 and Prolia. The study completed enrollment of 532 participants across multiple countries.

AI analysis

Indication: Osteoporosis, Postmenopausal

Modality: monoclonal antibody

Target: Osteoporosis, Postmenopausal

Sponsor: Alvotech Swiss AG

Source URL: ClinicalTrials.gov

Source updated: May 29, 2025

Ingested: Jun 03, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis, Postmenopausal

Condition normalized: Osteoporosis, Postmenopausal

Modality raw: Osteoporosis, Postmenopausal

Modality normalized: monoclonal antibody

Target raw: Osteoporosis, Postmenopausal

Target normalized: Osteoporosis, Postmenopausal

Open report
NCT07360080
Source recordAI-normalized

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

Sanofi is conducting a prospective cohort study to evaluate the long-term outcomes of teplizumab treatment in patients with Stage 2 Type 1 Diabetes. The study aims to assess the drug's effectiveness in delaying the onset of Stage 3 T1D and its impact on patients' quality of life through various patient-reported outcomes.

AI analysis

Indication: Type 1 Diabetes

Modality: monoclonal antibody

Target: Type 1 Diabetes (Stage 2)

Sponsor: Sanofi

Source URL: ClinicalTrials.gov

Source updated: May 27, 2026

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Type 1 Diabetes

Condition normalized: Type 1 Diabetes

Modality raw: Type 1 Diabetes

Modality normalized: monoclonal antibody

Target raw: Type 1 Diabetes (Stage 2)

Target normalized: Type 1 Diabetes (Stage 2)

Open report
NCT00385697
Source recordAI-normalized

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

The Protégé Study evaluated MGA031 (teplizumab), a humanized anti-CD3 monoclonal antibody, for its efficacy and safety in reducing insulin requirements and improving blood sugar levels in children and adults with recent-onset type 1 diabetes. Conducted by MacroGenics in collaboration with Eli Lilly, the trial enrolled 554 participants across multiple centers.

AI analysis

Indication: Type 1 Diabetes Mellitus

Modality: monoclonal antibody

Target: Type 1 Diabetes Mellitus

Sponsor: MacroGenics

Source URL: ClinicalTrials.gov

Source updated: Dec 05, 2023

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Type 1 Diabetes Mellitus

Condition normalized: Type 1 Diabetes Mellitus

Modality raw: Type 1 Diabetes Mellitus

Modality normalized: monoclonal antibody

Target raw: Type 1 Diabetes Mellitus

Target normalized: Type 1 Diabetes Mellitus

Open report
NCT00239720
Source recordAI-normalized

Treatment of Psoriatic Arthritis With hOKT3γ1 (Ala-Ala)

The clinical trial evaluated the safety and efficacy of hOKT3γ1 (Ala-Ala), a monoclonal antibody targeting CD3 on T cells, in patients with psoriatic arthritis unresponsive to standard therapies. The study was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and aimed to provide a new treatment option for patients with severe disease.

AI analysis

Indication: Arthritis, Psoriatic

Modality: monoclonal antibody

Target: Psoriatic Arthritis

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Source URL: ClinicalTrials.gov

Source updated: Apr 27, 2017

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Arthritis, Psoriatic

Condition normalized: Arthritis, Psoriatic

Modality raw: Arthritis, Psoriatic

Modality normalized: monoclonal antibody

Target raw: Psoriatic Arthritis

Target normalized: Psoriatic Arthritis

Open report
NCT03751007
Source recordAI-normalized

A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)

The clinical trial assessed the safety and tolerability of AG019, both as a monotherapy and in combination with Teplizumab, in patients with recent-onset Type 1 Diabetes. Conducted by Precigen Actobio T1D, LLC, the study aimed to evaluate different dosing regimens across two age groups (12-17 and 18-40 years).

AI analysis

Indication: Diabetes type1

Modality: monoclonal antibody

Target: Type 1 Diabetes (T1D)

Sponsor: Precigen Actobio T1D, LLC

Source URL: ClinicalTrials.gov

Source updated: Feb 01, 2023

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Diabetes type1

Condition normalized: Diabetes type1

Modality raw: Diabetes type1

Modality normalized: monoclonal antibody

Target raw: Type 1 Diabetes (T1D)

Target normalized: Type 1 Diabetes (T1D)

Open report
NCT00870818
Source recordAI-normalized

An Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Patients With Recent-Onset Type 1 Diabetes Mellitus

The study aimed to evaluate the long-term safety and efficacy of Teplizumab (MGA031), a monoclonal antibody, in patients with recent-onset Type 1 Diabetes Mellitus. The trial was sponsored by MacroGenics in collaboration with Eli Lilly and Company. It was terminated due to a business decision after enrolling 219 participants.

AI analysis

Indication: Type 1 Diabetes Mellitus

Modality: monoclonal antibody

Target: Type 1 Diabetes Mellitus

Sponsor: MacroGenics

Source URL: ClinicalTrials.gov

Source updated: Aug 09, 2023

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Type 1 Diabetes Mellitus

Condition normalized: Type 1 Diabetes Mellitus

Modality raw: Type 1 Diabetes Mellitus

Modality normalized: monoclonal antibody

Target raw: Type 1 Diabetes Mellitus

Target normalized: Type 1 Diabetes Mellitus

Open report
NCT00954915
Source recordAI-normalized

A Phase 2a, Open Label, Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Teplizumab in Adults With Moderate or More Severe Psoriasis

The study aimed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of teplizumab, a monoclonal antibody, in adults with moderate to severe psoriasis. The trial was sponsored by MacroGenics in collaboration with Eli Lilly and Company.

AI analysis

Indication: Psoriasis

Modality: monoclonal antibody

Target: Psoriasis

Sponsor: MacroGenics

Source URL: ClinicalTrials.gov

Source updated: Feb 10, 2022

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Psoriasis

Condition normalized: Psoriasis

Modality raw: Psoriasis

Modality normalized: monoclonal antibody

Target raw: Psoriasis

Target normalized: Psoriasis

Open report
NCT03875729
Source recordAI-normalized

Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

Provention Bio, Inc. conducted a Phase 3 trial to evaluate the efficacy and safety of teplizumab, a humanized anti-CD3 monoclonal antibody, in children and adolescents aged 8-17 with recent-onset Type 1 Diabetes (T1D). The study aimed to preserve β cell function and slow the loss of β cells over 18 months.

AI analysis

Indication: Type 1 Diabetes Mellitus

Modality: monoclonal antibody

Target: Type 1 Diabetes Mellitus

Sponsor: Provention Bio, Inc.

Source URL: ClinicalTrials.gov

Source updated: Apr 24, 2024

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Type 1 Diabetes Mellitus

Condition normalized: Type 1 Diabetes Mellitus

Modality raw: Type 1 Diabetes Mellitus

Modality normalized: monoclonal antibody

Target raw: Type 1 Diabetes Mellitus

Target normalized: Type 1 Diabetes Mellitus

Open report
NCT03867084
Source recordAI-normalized

A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)

This clinical trial evaluates the safety and efficacy of pembrolizumab (MK-3475) as adjuvant therapy in patients with HCC who have achieved complete radiological response following surgical resection or local ablation. The study aims to demonstrate superiority in recurrence-free survival (RFS) and overall survival (OS) compared to placebo.

AI analysis

Indication: Hepatocellular Carcinoma

Modality: monoclonal antibody

Target: Hepatocellular Carcinoma (HCC)

Sponsor: Merck Sharp & Dohme LLC

Source URL: ClinicalTrials.gov

Source updated: Apr 24, 2026

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Hepatocellular Carcinoma

Condition normalized: Hepatocellular Carcinoma

Modality raw: Hepatocellular Carcinoma

Modality normalized: monoclonal antibody

Target raw: Hepatocellular Carcinoma (HCC)

Target normalized: Hepatocellular Carcinoma (HCC)

Open report
NCT01055314
Source recordAI-normalized

A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody NSC # 742460]) in Combination With Intensive Multi-agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma

This pilot study evaluated the feasibility and efficacy of combining temozolomide and cixutumumab with a multi-agent chemotherapy regimen for high-risk metastatic rhabdomyosarcoma in children and adults. The study was sponsored by the National Cancer Institute and involved 175 participants.

AI analysis

Indication: Adult Rhabdomyosarcoma

Modality: monoclonal antibody

Target: Metastatic Rhabdomyosarcoma

Sponsor: National Cancer Institute (NCI)

Source URL: ClinicalTrials.gov

Source updated: Aug 29, 2017

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Adult Rhabdomyosarcoma

Condition normalized: Adult Rhabdomyosarcoma

Modality raw: Adult Rhabdomyosarcoma

Modality normalized: monoclonal antibody

Target raw: Metastatic Rhabdomyosarcoma

Target normalized: Metastatic Rhabdomyosarcoma

Open report
NCT00687882
Source recordAI-normalized

Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children

The Kids-DOTT trial evaluates the non-inferiority of a shortened duration (6 weeks) versus conventional duration (3 months) of anticoagulation therapy in children with first-episode acute venous thrombosis. The study aims to enroll 750 children across 40 centers, focusing on safety and efficacy outcomes related to recurrent venous thromboembolism (VTE) and bleeding.

AI analysis

Indication: Venous Thrombosis

Modality: monoclonal antibody

Target: Venous Thrombosis in Children

Sponsor: Johns Hopkins All Children's Hospital

Source URL: ClinicalTrials.gov

Source updated: Jun 18, 2025

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Venous Thrombosis

Condition normalized: Venous Thrombosis

Modality raw: Venous Thrombosis

Modality normalized: monoclonal antibody

Target raw: Venous Thrombosis in Children

Target normalized: Venous Thrombosis in Children

Open report
NCT03518320
Source recordAI-normalized

A Multicenter Study of TAR-200 in Combination With Nivolumab (OPDIVO) in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

The clinical trial investigated the safety and tolerability of TAR-200, a drug delivery system, in combination with Nivolumab for patients with muscle-invasive bladder cancer (MIBC) scheduled for radical cystectomy. The study was sponsored by Taris Biomedical LLC in collaboration with Bristol-Myers Squibb.

AI analysis

Indication: Bladder Cancer TNM Staging Primary Tumor (T) T2

Modality: monoclonal antibody

Target: Muscle-Invasive Bladder Cancer

Sponsor: Taris Biomedical LLC

Source URL: ClinicalTrials.gov

Source updated: Aug 27, 2024

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Bladder Cancer TNM Staging Primary Tumor (T) T2

Condition normalized: Bladder Cancer TNM Staging Primary Tumor (T) T2

Modality raw: Bladder Cancer TNM Staging Primary Tumor (T) T2

Modality normalized: monoclonal antibody

Target raw: Muscle-Invasive Bladder Cancer

Target normalized: Muscle-Invasive Bladder Cancer

Open report
NCT05757713
Source recordAI-normalized

Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)

Sanofi is conducting a single-arm, open-label clinical trial to evaluate the safety and pharmacokinetics of teplizumab in pediatric patients under 8 years of age with Stage 2 Type 1 Diabetes. The study aims to enroll approximately 20 participants and will assess treatment-emergent adverse events, pharmacokinetics, and immunogenicity over a period of up to 26 months.

AI analysis

Indication: Diabetes Mellitus, Type 1

Modality: monoclonal antibody

Target: Type 1 Diabetes (Stage 2)

Sponsor: Sanofi

Source URL: ClinicalTrials.gov

Source updated: Jan 30, 2026

Ingested: May 31, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Diabetes Mellitus, Type 1

Condition normalized: Diabetes Mellitus, Type 1

Modality raw: Diabetes Mellitus, Type 1

Modality normalized: monoclonal antibody

Target raw: Type 1 Diabetes (Stage 2)

Target normalized: Type 1 Diabetes (Stage 2)

Open report
NCT04936308
Source recordAI-normalized

A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent

This clinical trial evaluates the efficacy and safety of Guselkumab in patients with active psoriatic arthritis who have had an inadequate response or intolerance to one prior anti-TNF alpha agent. The study is sponsored by Janssen Research & Development, LLC and aims to establish Guselkumab as a viable treatment option in this patient population.

AI analysis

Indication: Arthritis, Psoriatic

Modality: monoclonal antibody

Target: Guselkumab

Sponsor: Janssen Research & Development, LLC

Source URL: ClinicalTrials.gov

Source updated: May 08, 2026

Ingested: May 30, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Arthritis, Psoriatic

Condition normalized: Arthritis, Psoriatic

Modality raw: Arthritis, Psoriatic

Modality normalized: monoclonal antibody

Target raw: Guselkumab

Target normalized: Guselkumab

Open report
NCT04338529
Source recordAI-normalized

Alendronate in an Weekly Effervescent Tablet Formulation for Preservation of Bone Mass After Denosumab Discontinuation in Postmenopausal Women with Low Bone Mass. an Observational Study (Binosto After Denosumab - the BAD Study)

This study investigates the efficacy of transitioning from denosumab to oral alendronate in a weekly effervescent tablet formulation for preserving bone mineral density (BMD) in postmenopausal women with low bone mass. The study aims to provide insights into optimal treatment duration and management strategies following denosumab discontinuation.

AI analysis

Indication: Postmenopausal Osteoporosis

Modality: monoclonal antibody

Target: Postmenopausal Osteoporosis

Sponsor: 251 Hellenic Air Force & VA General Hospital

Source URL: ClinicalTrials.gov

Source updated: Dec 02, 2024

Ingested: May 30, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Postmenopausal Osteoporosis

Condition normalized: Postmenopausal Osteoporosis

Modality raw: Postmenopausal Osteoporosis

Modality normalized: monoclonal antibody

Target raw: Postmenopausal Osteoporosis

Target normalized: Postmenopausal Osteoporosis

Open report
NCT05366621
Source recordAI-normalized

The Association Between Anti-osteoporosis Medications and Lowered All Cause Mortality After Osteoporotic Fractures

This observational study aimed to assess the relationship between anti-osteoporosis medications and all-cause mortality in older adults following osteoporotic fractures. Conducted by National Cheng-Kung University Hospital, it involved a cohort of 216,155 participants and spanned a 12-year observation period.

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: Osteoporosis and Mortality

Sponsor: National Cheng-Kung University Hospital

Source URL: ClinicalTrials.gov

Source updated: Apr 04, 2023

Ingested: May 30, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis

Condition normalized: Osteoporosis

Modality raw: Osteoporosis

Modality normalized: monoclonal antibody

Target raw: Osteoporosis and Mortality

Target normalized: Osteoporosis and Mortality

Open report
NCT06076772
Source recordAI-normalized

Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients

This study aims to assess the risk factors and treatment outcomes associated with neutropenia induced by Palbociclib in patients with hormone receptor-positive, HER2-negative metastatic breast cancer. The study will evaluate progression-free survival (PFS) and overall survival (OS) over a two-year period, providing insights into the pharmacodynamics of Palbociclib and potential dose optimization strategies.

AI analysis

Indication: Metastatic Breast Cancer

Modality: monoclonal antibody

Target: Palbociclib-induced neutropenia in metastatic breast cancer patients

Sponsor: Assiut University

Source URL: ClinicalTrials.gov

Source updated: Oct 11, 2023

Ingested: May 30, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Metastatic Breast Cancer

Condition normalized: Metastatic Breast Cancer

Modality raw: Metastatic Breast Cancer

Modality normalized: monoclonal antibody

Target raw: Palbociclib-induced neutropenia in metastatic breast cancer patients

Target normalized: Palbociclib-induced neutropenia in metastatic breast cancer patients

Open report
NCT01572545
Source recordAI-normalized

Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin Levels of Postmenopausal Women With Low Bone Mass: A Multicenter, Randomized, Head-to-head Clinical Trial

This completed clinical trial compared the effects of Zoledronic Acid and Denosumab on serum sclerostin levels, a key biomarker in bone metabolism, in postmenopausal women with low bone mass. The study aimed to provide insights into the efficacy of these two leading osteoporosis treatments.

AI analysis

Indication: Postmenopausal Osteoporosis

Modality: monoclonal antibody

Target: Serum sclerostin levels in postmenopausal women with low bone mass

Sponsor: Aristotle University Of Thessaloniki

Source URL: ClinicalTrials.gov

Source updated: Jan 17, 2013

Ingested: May 30, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Postmenopausal Osteoporosis

Condition normalized: Postmenopausal Osteoporosis

Modality raw: Postmenopausal Osteoporosis

Modality normalized: monoclonal antibody

Target raw: Serum sclerostin levels in postmenopausal women with low bone mass

Target normalized: Serum sclerostin levels in postmenopausal women with low bone mass

Open report
NCT06272227
Source recordAI-normalized

Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients; Double-blinded Randomized Controlled Trial

This clinical trial, sponsored by Yonsei University, aims to evaluate the efficacy of alfacalcidol in enhancing muscle function in postmenopausal women with osteoporosis and functional sarcopenia. The study will involve 340 participants over a one-year period, comparing outcomes between the alfacalcidol and placebo groups.

AI analysis

Indication: Sarcopenia

Modality: monoclonal antibody

Target: Muscle function improvement in osteoporosis patients

Sponsor: Yonsei University

Source URL: ClinicalTrials.gov

Source updated: Feb 22, 2024

Ingested: May 30, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Sarcopenia

Condition normalized: Sarcopenia

Modality raw: Sarcopenia

Modality normalized: monoclonal antibody

Target raw: Muscle function improvement in osteoporosis patients

Target normalized: Muscle function improvement in osteoporosis patients

Open report
NCT05389462
Source recordAI-normalized

A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors

ADC Therapeutics S.A. initiated a clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-601 in patients with advanced solid tumors, particularly focusing on sarcomas and pancreatic cancer. The study aimed to establish the recommended phase 2 dose and assess the drug's efficacy in combination with gemcitabine.

AI analysis

Indication: Advanced Solid Tumors

Modality: monoclonal antibody

Target: Mipasetamab Uzoptirine (ADCT-601)

Sponsor: ADC Therapeutics S.A.

Source URL: ClinicalTrials.gov

Source updated: May 22, 2025

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Advanced Solid Tumors

Condition normalized: Advanced Solid Tumors

Modality raw: Advanced Solid Tumors

Modality normalized: monoclonal antibody

Target raw: Mipasetamab Uzoptirine (ADCT-601)

Target normalized: Mipasetamab Uzoptirine (ADCT-601)

Open report
NCT05353179
Source recordAI-normalized

Phase I, Single-center, Randomized, Double-blind, Single-dose, Parallel Comparison of Pharmacokinetic and Safety Similarities Between Meperizumab Injection and NUCALA® in Healthy Male Volunteers

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is conducting a Phase I clinical trial to evaluate the pharmacokinetics and safety of Meperizumab injection compared to NUCALA® in healthy male volunteers. The study aims to enroll 88 subjects and assess the similarity in drug behavior and safety profiles.

AI analysis

Indication: Granulomatosis With Polyangiitis

Modality: monoclonal antibody

Target: Meperizumab injection (humanized monoclonal antibody targeting IL-5 receptor)

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Source URL: ClinicalTrials.gov

Source updated: Apr 29, 2022

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Granulomatosis With Polyangiitis

Condition normalized: Granulomatosis With Polyangiitis

Modality raw: Granulomatosis With Polyangiitis

Modality normalized: monoclonal antibody

Target raw: Meperizumab injection (humanized monoclonal antibody targeting IL-5 receptor)

Target normalized: Meperizumab injection (humanized monoclonal antibody targeting IL-5 receptor)

Open report
NCT02658084
Source recordAI-normalized

A Phase I/II Study to Evaluate the Safety and Efficacy of Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer

The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: Vinorelbine, Trastuzumab Emtansine

Sponsor: University of Miami

Source URL: ClinicalTrials.gov

Source updated: Apr 17, 2019

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer

Condition normalized: Breast Cancer

Modality raw: Breast Cancer

Modality normalized: monoclonal antibody

Target raw: Vinorelbine, Trastuzumab Emtansine

Target normalized: Vinorelbine, Trastuzumab Emtansine

Open report
NCT06663787
Source recordAI-normalized

Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment

This clinical trial aims to evaluate the status of circulating tumor DNA (ctDNA) in patients with HER2-positive metastatic breast cancer who have achieved a durable response to anti-HER2 treatment. The study utilizes the Signatera™ ctDNA assay to assess minimal residual disease (MRD) and explore potential new therapeutic strategies, including the possibility of de-escalating treatment in ctDNA-negative patients.

AI analysis

Indication: Breast Cancer, Metastatic

Modality: monoclonal antibody

Target: HER2-positive metastatic breast cancer

Sponsor: Nagoya City University

Source URL: ClinicalTrials.gov

Source updated: May 13, 2026

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer, Metastatic, HER2 + Breast Cancer

Condition normalized: Breast Cancer, Metastatic, HER2 + Breast Cancer

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Trastuzumab (Herceptin), SIgnatera

Target normalized: HER2-positive metastatic breast cancer

Open report
NCT03878524
Source recordAI-normalized

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIME

This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.

AI analysis

Indication: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Modality: monoclonal antibody

Target: Abemaciclib, Abiraterone, Afatinib, Bevacizumab, Bicalutamide, Biospecimen Collection, Bortezomib, Cabazitaxel, Cabozantinib, Capecitabine, Carboplatin, Celecoxib, Cobimetinib, Copanlisib, Dabrafenib, Dacomitinib, Darolutamide, Dasatinib, Doxorubicin, Durvalumab, Enasidenib, Entrectinib, Enzalutamide, Erlotinib, Everolimus, Fluorouracil, Idelalisib, Imatinib, Ipilimumab, Lenvatinib, Leucovorin, Lorlatinib, Losartan, Nab-paclitaxel, Neratinib, Nivolumab, Olaparib, Oxaliplatin, Palbociclib, Panobinostat, Pembrolizumab, Pertuzumab, Ponatinib, Quality-of-Life Assessment, Regorafenib, Ruxolitinib, Sirolimus, Sorafenib, Sunitinib, Trametinib, Trastuzumab Emtansine, Tretinoin, Vemurafenib, Venetoclax, Vismodegib, Vorinostat

Sponsor: OHSU Knight Cancer Institute

Source URL: ClinicalTrials.gov

Source updated: Mar 04, 2024

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Condition normalized: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Modality raw: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Modality normalized: monoclonal antibody

Target raw: Abemaciclib, Abiraterone, Afatinib, Bevacizumab, Bicalutamide, Biospecimen Collection, Bortezomib, Cabazitaxel, Cabozantinib, Capecitabine, Carboplatin, Celecoxib, Cobimetinib, Copanlisib, Dabrafenib, Dacomitinib, Darolutamide, Dasatinib, Doxorubicin, Durvalumab, Enasidenib, Entrectinib, Enzalutamide, Erlotinib, Everolimus, Fluorouracil, Idelalisib, Imatinib, Ipilimumab, Lenvatinib, Leucovorin, Lorlatinib, Losartan, Nab-paclitaxel, Neratinib, Nivolumab, Olaparib, Oxaliplatin, Palbociclib, Panobinostat, Pembrolizumab, Pertuzumab, Ponatinib, Quality-of-Life Assessment, Regorafenib, Ruxolitinib, Sirolimus, Sorafenib, Sunitinib, Trametinib, Trastuzumab Emtansine, Tretinoin, Vemurafenib, Venetoclax, Vismodegib, Vorinostat

Target normalized: Abemaciclib, Abiraterone, Afatinib, Bevacizumab, Bicalutamide, Biospecimen Collection, Bortezomib, Cabazitaxel, Cabozantinib, Capecitabine, Carboplatin, Celecoxib, Cobimetinib, Copanlisib, Dabrafenib, Dacomitinib, Darolutamide, Dasatinib, Doxorubicin, Durvalumab, Enasidenib, Entrectinib, Enzalutamide, Erlotinib, Everolimus, Fluorouracil, Idelalisib, Imatinib, Ipilimumab, Lenvatinib, Leucovorin, Lorlatinib, Losartan, Nab-paclitaxel, Neratinib, Nivolumab, Olaparib, Oxaliplatin, Palbociclib, Panobinostat, Pembrolizumab, Pertuzumab, Ponatinib, Quality-of-Life Assessment, Regorafenib, Ruxolitinib, Sirolimus, Sorafenib, Sunitinib, Trametinib, Trastuzumab Emtansine, Tretinoin, Vemurafenib, Venetoclax, Vismodegib, Vorinostat

Open report
NCT01513083
Source recordAI-normalized

A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: trastuzumab emtansine

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Nov 02, 2016

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer

Condition normalized: Breast Cancer

Modality raw: Breast Cancer

Modality normalized: monoclonal antibody

Target raw: trastuzumab emtansine

Target normalized: trastuzumab emtansine

Open report
NCT01853748
Source recordAI-normalized

A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study. The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer. In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: Trastuzumab, Paclitaxel, Trastuzumab emtansine

Sponsor: Dana-Farber Cancer Institute

Source URL: ClinicalTrials.gov

Source updated: Feb 19, 2026

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer

Condition normalized: Breast Cancer

Modality raw: Breast Cancer

Modality normalized: monoclonal antibody

Target raw: Trastuzumab, Paclitaxel, Trastuzumab emtansine

Target normalized: Trastuzumab, Paclitaxel, Trastuzumab emtansine

Open report
NCT00679341
Source recordAI-normalized

A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic breast cancer who have not received prior chemotherapy for metastatic disease.

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Sponsor: Hoffmann-La Roche

Source URL: ClinicalTrials.gov

Source updated: Jan 09, 2014

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer

Condition normalized: Breast Cancer

Modality raw: Breast Cancer

Modality normalized: monoclonal antibody

Target raw: Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Target normalized: Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel

Open report
NCT04769050
Source recordAI-normalized

A Phase II, Single-center, Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment

Dynamic observationaL study with PET of 68Ga-HER2-affibody in anti-HER2 treatment

AI analysis

Indication: Breast Cancer

Modality: monoclonal antibody

Target: Docetaxel combined with Trastuzumab±Pertuzumab, T-DM1 or Capecitabine combined with Pyrotinib regimen.

Sponsor: Fudan University

Source URL: ClinicalTrials.gov

Source updated: Apr 20, 2022

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer

Condition normalized: Breast Cancer

Modality raw: Breast Cancer

Modality normalized: monoclonal antibody

Target raw: Docetaxel combined with Trastuzumab±Pertuzumab, T-DM1 or Capecitabine combined with Pyrotinib regimen.

Target normalized: Docetaxel combined with Trastuzumab±Pertuzumab, T-DM1 or Capecitabine combined with Pyrotinib regimen.

Open report
NCT01745757
Source recordAI-normalized

Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab (AVASTIN ®) in Combination With Weekly Paclitaxel Chemotherapy in First Line Treatment Patients With Metastatic Breast Cancer

The COMET study, sponsored by UNICANCER, aimed to validate predictive factors and biological imaging related to the response of metastatic breast cancer patients to Bevacizumab and Paclitaxel. The study enrolled 510 patients and was completed in December 2022. It focused on identifying biomarkers that could help tailor treatments and improve patient outcomes.

AI analysis

Indication: Metastatic

Modality: monoclonal antibody

Target: Metastatic Breast Cancer

Sponsor: UNICANCER

Source URL: ClinicalTrials.gov

Source updated: Jan 27, 2023

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Metastatic

Condition normalized: Metastatic

Modality raw: Metastatic

Modality normalized: monoclonal antibody

Target raw: Metastatic Breast Cancer

Target normalized: Metastatic Breast Cancer

Open report
NCT05502341
Source recordAI-normalized

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

This clinical trial, sponsored by Gilead Sciences, aims to evaluate the safety and efficacy of Bictegravir (BIC) and Lenacapavir (LEN) compared to current therapies in patients with HIV-1 who are virologically suppressed on complex treatment regimens. The study is designed as a randomized, open-label, multicenter trial with a total enrollment of 689 participants.

AI analysis

Indication: HIV-1-infection

Modality: monoclonal antibody

Target: HIV-1 infection

Sponsor: Gilead Sciences

Source URL: ClinicalTrials.gov

Source updated: Oct 14, 2025

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: HIV-1-infection

Condition normalized: HIV-1-infection

Modality raw: HIV-1-infection

Modality normalized: monoclonal antibody

Target raw: HIV-1 infection

Target normalized: HIV-1 infection

Open report
NCT04170283
Source recordAI-normalized

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies

This long-term extension study evaluates the safety and efficacy of zanubrutinib (BGB-3111) in patients with B-cell malignancies who have previously participated in a parent study. The study aims to provide insights into the long-term effects and potential benefits of continued treatment with zanubrutinib, either alone or in combination with Tislelizumab.

AI analysis

Indication: B-cell Malignancies

Modality: monoclonal antibody

Target: B-cell Malignancies

Sponsor: BeiGene

Source URL: ClinicalTrials.gov

Source updated: Oct 21, 2025

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: B-cell Malignancies

Condition normalized: B-cell Malignancies

Modality raw: B-cell Malignancies

Modality normalized: monoclonal antibody

Target raw: B-cell Malignancies

Target normalized: B-cell Malignancies

Open report
NCT01652690
Source recordAI-normalized

Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice

This study aimed to characterize the management of postmenopausal osteoporosis patients treated with denosumab in routine clinical practice across the Czech Republic and Slovakia. It involved 600 participants and focused on treatment adherence and safety data over a 24-month period.

AI analysis

Indication: Osteoporosis, Postmenopausal

Modality: monoclonal antibody

Target: Denosumab (Prolia®)

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Mar 06, 2019

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis, Postmenopausal

Condition normalized: Osteoporosis, Postmenopausal

Modality raw: Osteoporosis, Postmenopausal

Modality normalized: monoclonal antibody

Target raw: Denosumab (Prolia®)

Target normalized: Denosumab (Prolia®)

Open report
NCT02299817
Source recordAI-normalized

Denosumab for Treating Periprosthetic Osteolysis After Uncemented Total Hip Arthroplasty A Randomized, Double-blind, Placebo-controlled Trial Using Volumetric Computed Tomography

This clinical trial investigates the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants in total hip arthroplasty. The study aims to provide insights into the potential of denosumab as a treatment option for patients experiencing osteolysis post-surgery.

AI analysis

Indication: Osteolysis

Modality: monoclonal antibody

Target: Osteolysis

Sponsor: Olof Skoldenberg

Source URL: ClinicalTrials.gov

Source updated: Feb 07, 2019

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteolysis

Condition normalized: Osteolysis

Modality raw: Osteolysis

Modality normalized: monoclonal antibody

Target raw: Osteolysis

Target normalized: Osteolysis

Open report
NCT01799798
Source recordAI-normalized

TRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMAB

This pilot trial evaluated the efficacy of Denosumab, a RANKL antibody, in treating children aged 5-10 with Osteogenesis Imperfecta caused by COL1A1 or COL1A2 mutations. The study aimed to assess changes in bone mineral density (BMD) after 36 weeks of treatment.

AI analysis

Indication: Osteogenesis Imperfecta

Modality: monoclonal antibody

Target: Osteogenesis Imperfecta

Sponsor: University of Cologne

Source URL: ClinicalTrials.gov

Source updated: Jan 27, 2015

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteogenesis Imperfecta

Condition normalized: Osteogenesis Imperfecta

Modality raw: Osteogenesis Imperfecta

Modality normalized: monoclonal antibody

Target raw: Osteogenesis Imperfecta

Target normalized: Osteogenesis Imperfecta

Open report
NCT05876949
Source recordAI-normalized

A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva® in Healthy Male Subjects

AVT03 is a proposed biosimilar to Xgeva (denosumab), developed by Alvotech Swiss AG. The clinical trial aimed to compare the pharmacokinetic, safety, and immunogenicity profiles of AVT03 against the reference product in healthy male subjects aged 28 to 55. The study was completed with a total enrollment of 208 participants.

AI analysis

Indication: This is a Phase I Study Conducted in Healthy Volunteers

Modality: monoclonal antibody

Target: AVT03 (biosimilar to Denosumab)

Sponsor: Alvotech Swiss AG

Source URL: ClinicalTrials.gov

Source updated: May 15, 2025

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: This is a Phase I Study Conducted in Healthy Volunteers

Condition normalized: This is a Phase I Study Conducted in Healthy Volunteers

Modality raw: This is a Phase I Study Conducted in Healthy Volunteers

Modality normalized: monoclonal antibody

Target raw: AVT03 (biosimilar to Denosumab)

Target normalized: AVT03 (biosimilar to Denosumab)

Open report
NCT02239523
Source recordAI-normalized

Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.

This clinical trial evaluates the effectiveness of orthopedic interventions in managing osteoporosis in patients with fragility fractures. It aims to improve treatment adherence and conduct a cost-benefit analysis of the interventions. The study was conducted at Shaare Zedek Medical Center and involved 200 patients over 50 years old.

AI analysis

Indication: Osteoporotic Fracture

Modality: monoclonal antibody

Target: Osteoporosis management after hip fracture

Sponsor: Shaare Zedek Medical Center

Source URL: ClinicalTrials.gov

Source updated: Apr 05, 2019

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporotic Fracture

Condition normalized: Osteoporotic Fracture

Modality raw: Osteoporotic Fracture

Modality normalized: monoclonal antibody

Target raw: Osteoporosis management after hip fracture

Target normalized: Osteoporosis management after hip fracture

Open report
NCT03174366
Source recordAI-normalized

Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences frequently lead to below-knee amputation of the affected limb. Currently treatment options are limited, and no pharmaceutical treatment has been efficacious in the medical literature. The purpose of this pilot study is to investigate the potential of the medication denosumab for acute stage Charcot neuroarthropathy.

AI analysis

Indication: Charcot Joint of Foot

Modality: monoclonal antibody

Target: Denosumab

Sponsor: Western University of Health Sciences

Source URL: ClinicalTrials.gov

Source updated: Oct 23, 2019

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Charcot Joint of Foot

Condition normalized: Charcot Joint of Foot

Modality raw: monoclonal antibody

Modality normalized: monoclonal antibody

Target raw: Denosumab

Target normalized: Denosumab

Open report
NCT00089791
Source recordAI-normalized

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)

The FREEDOM trial evaluated the efficacy and safety of Denosumab, a monoclonal antibody, in reducing fractures in postmenopausal women with osteoporosis. Conducted by Amgen, the study enrolled 7,808 participants and demonstrated significant fracture risk reduction, positioning Denosumab as a competitive treatment option in the osteoporosis market.

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: Postmenopausal Osteoporosis

Sponsor: Amgen

Source URL: ClinicalTrials.gov

Source updated: Nov 08, 2022

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis

Condition normalized: Osteoporosis

Modality raw: Osteoporosis

Modality normalized: monoclonal antibody

Target raw: Postmenopausal Osteoporosis

Target normalized: Postmenopausal Osteoporosis

Open report
NCT05299073
Source recordAI-normalized

A Randomised, Double-blind, Three-arm, Single-dose, Parallel Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of MB09 (Denosumab Biosimilar) and EU/US-sourced Xgeva® in Healthy Male Volunteers

The clinical trial evaluated the pharmacokinetic (PK) similarity, pharmacodynamics (PD), safety, and immunogenicity of MB09, a biosimilar to Xgeva, in healthy male volunteers. The study was conducted by mAbxience Research S.L. and involved 257 participants across three arms: MB09, US-sourced Xgeva, and EU-sourced Xgeva.

AI analysis

Indication: Healthy Volunteers

Modality: monoclonal antibody

Target: Denosumab Biosimilar (MB09)

Sponsor: mAbxience Research S.L.

Source URL: ClinicalTrials.gov

Source updated: Jan 03, 2025

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Healthy Volunteers

Condition normalized: Healthy Volunteers

Modality raw: Healthy Volunteers

Modality normalized: monoclonal antibody

Target raw: Denosumab Biosimilar (MB09)

Target normalized: Denosumab Biosimilar (MB09)

Open report
NCT03869762
Source recordAI-normalized

A Phase II Study of Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases.

The DICE trial investigated the combination of Denosumab and Enzalutamide in patients with progressive metastatic castration-resistant prostate cancer and bone metastases. The study was terminated due to insufficient patient accrual, with only 7 participants enrolled.

AI analysis

Indication: Castration-resistant Prostate Cancer

Modality: monoclonal antibody

Target: Castration-resistant Prostate Cancer

Sponsor: Cancer Trials Ireland

Source URL: ClinicalTrials.gov

Source updated: Apr 13, 2026

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Castration-resistant Prostate Cancer

Condition normalized: Castration-resistant Prostate Cancer

Modality raw: Castration-resistant Prostate Cancer

Modality normalized: monoclonal antibody

Target raw: Castration-resistant Prostate Cancer

Target normalized: Castration-resistant Prostate Cancer

Open report
NCT03401060
Source recordAI-normalized

Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis

This clinical trial evaluates the efficacy of Denosumab, an anti-RANKL monoclonal antibody, in improving bone mineral density (BMD) in patients with osteoporosis due to systemic mastocytosis. The study is sponsored by Assistance Publique - Hôpitaux de Paris and involves a randomized, double-blind design comparing Denosumab to a placebo over three years.

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: Osteoporosis associated with systemic mastocytosis

Sponsor: Assistance Publique - Hôpitaux de Paris

Source URL: ClinicalTrials.gov

Source updated: Mar 31, 2026

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis

Condition normalized: Osteoporosis

Modality raw: Osteoporosis

Modality normalized: monoclonal antibody

Target raw: Osteoporosis associated with systemic mastocytosis

Target normalized: Osteoporosis associated with systemic mastocytosis

Open report
NCT04241211
Source recordAI-normalized

Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial

This clinical trial investigates the efficacy of Teriparatide (Forsteo) compared to Denosumab (Prolia) in reducing the incidence of Proximal Junctional Kyphosis (PJK) following Adult Spinal Deformity (ASD) surgery. The study is being conducted at Seoul National University Bundang Hospital and aims to provide insights into effective medical therapies for PJK prevention.

AI analysis

Indication: Spine Deformity

Modality: monoclonal antibody

Target: Proximal Junctional Kyphosis (PJK)

Sponsor: Seoul National University Bundang Hospital

Source URL: ClinicalTrials.gov

Source updated: Jan 27, 2020

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Spine Deformity

Condition normalized: Spine Deformity

Modality raw: Spine Deformity

Modality normalized: monoclonal antibody

Target raw: Proximal Junctional Kyphosis (PJK)

Target normalized: Proximal Junctional Kyphosis (PJK)

Open report
NCT06154707
Source recordAI-normalized

Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes

This clinical trial aims to evaluate the efficacy of Denosumab in treating osteoporosis and its impact on sarcopenia in a domestic population. The study involves a randomized controlled design with an estimated enrollment of 86 participants, comparing Denosumab treatment against a placebo over a 12-month period.

AI analysis

Indication: Sarcopenia

Modality: monoclonal antibody

Target: Osteoporosis and Sarcopenia

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Source URL: ClinicalTrials.gov

Source updated: Aug 16, 2024

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Sarcopenia

Condition normalized: Sarcopenia

Modality raw: Sarcopenia

Modality normalized: monoclonal antibody

Target raw: Osteoporosis and Sarcopenia

Target normalized: Osteoporosis and Sarcopenia

Open report
NCT02682693
Source recordAI-normalized

Investigating Denosumab as an add-on Neoadjuvant Treatment for RANK-positive or RANK-negative Primary Breast Cancer and Two Different Nab-Paclitaxel Schedules ; 2x2 Factorial Design (GeparX)

The GeparX trial investigated denosumab as an adjunct to neoadjuvant chemotherapy in patients with RANK-positive breast cancer. Conducted by GBG Forschungs GmbH in collaboration with Amgen and Celgene, the study aimed to enhance pathological complete response (pCR) rates and improve patient outcomes. The trial enrolled 780 participants and was completed in December 2020.

AI analysis

Indication: Breast Cancer Female NOS

Modality: monoclonal antibody

Target: RANK-positive or RANK-negative Primary Breast Cancer

Sponsor: GBG Forschungs GmbH

Source URL: ClinicalTrials.gov

Source updated: Feb 02, 2021

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Breast Cancer Female NOS

Condition normalized: Breast Cancer Female NOS

Modality raw: Breast Cancer Female NOS

Modality normalized: monoclonal antibody

Target raw: RANK-positive or RANK-negative Primary Breast Cancer

Target normalized: RANK-positive or RANK-negative Primary Breast Cancer

Open report
NCT04467983
Source recordAI-normalized

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

This clinical trial evaluates the efficacy of adding abaloparatide to ongoing denosumab treatment in postmenopausal women with osteoporosis. The study aims to determine if this combination therapy can improve bone mineral density (BMD) compared to continued denosumab alone. The trial is sponsored by the Hospital for Special Surgery in New York, with collaboration from Radius Health, Inc.

AI analysis

Indication: Osteoporosis, Postmenopausal

Modality: monoclonal antibody

Target: Osteoporosis, Postmenopausal

Sponsor: Hospital for Special Surgery, New York

Source URL: ClinicalTrials.gov

Source updated: May 02, 2025

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis, Postmenopausal

Condition normalized: Osteoporosis, Postmenopausal

Modality raw: Osteoporosis, Postmenopausal

Modality normalized: monoclonal antibody

Target raw: Osteoporosis, Postmenopausal

Target normalized: Osteoporosis, Postmenopausal

Open report
NCT02166437
Source recordAI-normalized

Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study

This clinical trial investigates the efficacy of bisphosphonate and denosumab therapies following teriparatide treatment in Japanese patients with severe osteoporosis. The study aims to analyze bone mineral density (BMD), bone turnover markers, and fracture prevention effects in a cohort of 500 patients.

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: Osteoporosis

Sponsor: Tomidahama Hospital

Source URL: ClinicalTrials.gov

Source updated: Oct 19, 2016

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis

Condition normalized: Osteoporosis

Modality raw: Osteoporosis

Modality normalized: monoclonal antibody

Target raw: Osteoporosis

Target normalized: Osteoporosis

Open report
NCT02435147
Source recordAI-normalized

Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index

This study evaluated the long-term effects of denosumab on trabecular bone score (TBS) and femur strength index (FSI) in postmenopausal women with osteoporosis. Conducted by HealthEast Care System, the observational study involved 86 participants, with 75 completing the study. The findings support denosumab's role in improving bone health metrics over 36 months.

AI analysis

Indication: Osteoporosis

Modality: monoclonal antibody

Target: denosumab

Sponsor: HealthEast Care System

Source URL: ClinicalTrials.gov

Source updated: Oct 29, 2018

Ingested: May 23, 2026

Model: trialsignal-ai-v1

Validation: validated

Matched by modality_normalized: monoclonal antibody

View original source fields

Condition raw: Osteoporosis, Bone Fracture

Condition normalized: Osteoporosis, Bone Fracture

Modality raw: small molecule

Modality normalized: monoclonal antibody

Target raw: denosumab

Target normalized: denosumab

Open report