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NCT06620302RECRUITINGanonymous

DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma

Sponsor

Source record

Children's Oncology Group

Phase

Source record

Phase 1/2

Modality

AI-normalized

protein therapy

Target

AI-normalized

Bcl-xL (B-cell lymphoma-extra large) protein, a key anti-apoptotic protein involved in tumor cell survival.

Indication / condition

AI-normalized

Childhood Fibrolamellar Carcinoma

Intervention

Source record

Bcl-XL Proteolysis Targeting Chimera DT2216, Biospecimen Collection, Irinotecan

Source & freshness

Source record

NCT ID

NCT06620302

Original source

ClinicalTrials.gov

Source last updated

May 05, 2026

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

NCT06620302

Title

DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma

Sponsor

Children's Oncology Group

Status

RECRUITING

Phase

Phase 1/2

Condition raw

Childhood Fibrolamellar Carcinoma, Recurrent Childhood Fibrolamellar Carcinoma, Recurrent Childhood Malignant Solid Neoplasm, Recurrent Fibrolamellar Carcinoma, Recurrent Malignant Solid Neoplasm, Refractory Childhood Fibrolamellar Carcinoma, Refractory Childhood Malignant Solid Neoplasm, Refractory Fibrolamellar Carcinoma, Refractory Malignant Solid Neoplasm

Condition normalized

Childhood Fibrolamellar Carcinoma, Recurrent Childhood Fibrolamellar Carcinoma, Recurrent Childhood Malignant Solid Neoplasm, Recurrent Fibrolamellar Carcinoma, Recurrent Malignant Solid Neoplasm, Refractory Childhood Fibrolamellar Carcinoma, Refractory Childhood Malignant Solid Neoplasm, Refractory Fibrolamellar Carcinoma, Refractory Malignant Solid Neoplasm

Modality raw

protein therapy

Modality normalized

protein therapy

Target raw

Bcl-xL (B-cell lymphoma-extra large) protein, a key anti-apoptotic protein involved in tumor cell survival.

Target normalized

Bcl-xL (B-cell lymphoma-extra large) protein, a key anti-apoptotic protein involved in tumor cell survival.

Interventions

Bcl-XL Proteolysis Targeting Chimera DT2216, Biospecimen Collection, Irinotecan

Public preview

Source record

The trial is sponsored by the Children's Oncology Group and aims to evaluate the safety and efficacy of DT2216 in combination with irinotecan for treating relapsed or refractory solid tumors, particularly fibrolamellar carcinoma (FLC) in pediatric and young adult populations. Given the limited treatment options for these patient groups, successful outcomes could position DT2216 as a novel therapeutic option, potentially capturing a niche market in pediatric oncology. The combination therapy may also enhance the competitive landscape against existing treatments, particularly for FLC, which has a unique molecular profile. The trial's focus on a specific genetic marker (DNAJB1:PRKACA fusion) in FLC could provide a targeted approach, appealing to precision medicine strategies in oncology. Stakeholders should monitor the trial's progress closely for potential partnership or acquisition opportunities, especially if early results indicate significant efficacy.

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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TrialSignal

Clinical trial intelligence report

DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT06620302

Status

RECRUITING

Phase

Phase 1/2

Sponsor

Children's Oncology Group

Executive brief

Investment-Ready Snapshot

The trial is sponsored by the Children's Oncology Group and aims to evaluate the safety and efficacy of DT2216 in combination with irinotecan for treating relapsed or refractory solid tumors, particularly fibrolamellar carcinoma (FLC) in pediatric and young adult populations. Given the limited treatment options for these patient groups, successful outcomes could position DT2216 as a novel therapeutic option, potentially capturing a niche market in pediatric oncology. The combination therapy may also enhance the competitive landscape against existing treatments, particularly for FLC, which has a unique molecular profile. The trial's focus on a specific genetic marker (DNAJB1:PRKACA fusion) in FLC could provide a targeted approach, appealing to precision medicine strategies in oncology. Stakeholders should monitor the trial's progress closely for potential partnership or acquisition opportunities, especially if early results indicate significant efficacy.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMay 05, 2026
Internal syncJun 12, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT06620302

Indication

Childhood Fibrolamellar Carcinoma

Modality

protein therapy

Target

Bcl-xL (B-cell lymphoma-extra large) protein, a key anti-apoptotic protein involved in tumor cell survival.

Intervention

Bcl-XL Proteolysis Targeting Chimera DT2216, Biospecimen Collection, Irinotecan

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.