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NCT05946226UNKNOWNanonymous

A Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of IMC002 in Patients With Claudin18.2-positive Advanced Digestive System Tumors

Sponsor

Source record

Suzhou Immunofoco Biotechnology Co., Ltd

Phase

Source record

Phase 1

Modality

AI-normalized

protein therapy

Target

AI-normalized

Claudin 18.2 (CLDN18.2)

Indication / condition

AI-normalized

Advanced Digestive System Tumor

Intervention

Source record

IMC002 injection

Source & freshness

Source record

NCT ID

NCT05946226

Original source

ClinicalTrials.gov

Source last updated

Sep 28, 2023

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05946226

Title

A Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of IMC002 in Patients With Claudin18.2-positive Advanced Digestive System Tumors

Sponsor

Suzhou Immunofoco Biotechnology Co., Ltd

Status

UNKNOWN

Phase

Phase 1

Condition raw

Advanced Digestive System Tumor

Condition normalized

Advanced Digestive System Tumor

Modality raw

protein therapy

Modality normalized

protein therapy

Target raw

Claudin 18.2 (CLDN18.2)

Target normalized

Claudin 18.2 (CLDN18.2)

Interventions

IMC002 injection

Public preview

Source record

IMC002 is being developed by Suzhou Immunofoco Biotechnology Co., Ltd as a potential treatment for advanced digestive system tumors that express CLDN18.2, including gastric and pancreatic cancers. The market for targeted therapies in these indications is significant, given the high unmet need and the limitations of current standard-of-care treatments. The competitive landscape includes other CAR-T therapies targeting similar antigens, necessitating a robust differentiation strategy based on safety and efficacy profiles. The trial's focus on a specific biomarker (CLDN18.2) may enhance patient selection and improve treatment outcomes, potentially leading to a favorable market position if successful. Diligence should focus on regulatory pathways, especially given the complexities associated with CAR-T therapies, and the need for comprehensive safety data to support future commercialization efforts.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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