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NCT06620302 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma
A Phase 1 study of Refractory Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT06620302 is a Phase 1 study of Refractory Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 81 participants, above the 63-participant average among 59 other Refractory Malignant Solid Neoplasm trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 17 states.
The verdict
NCT06620302, a Phase 1 study of Refractory Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking Bcl-xL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Irinotecan
- BIOLOGICAL Bcl-XL Proteolysis Targeting Chimera DT2216
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Alabama
- Children's Hospital of Alabama - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Arthur M Blank Hospital - Atlanta
Illinois
- Lurie Children's Hospital-Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2025-06-12 |
| Est. Completion | 2031-12-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06620302
The ClinicalTrials.gov registry entry for NCT06620302 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 63-participant average among 59 other Refractory Malignant Solid Neoplasm trials with a reported enrollment target (29% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Refractory Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT06620302 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06620302 about?
NCT06620302 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma". This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not ...
What is the current status of trial NCT06620302?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2025-06-12. Estimated completion is 2031-12-30.
What conditions does trial NCT06620302 study?
This clinical trial studies the following conditions: Refractory Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Childhood Fibrolamellar Carcinoma, Recurrent Childhood Fibrolamellar Carcinoma, Recurrent Childhood Malignant Solid Neoplasm.
What interventions are being tested in trial NCT06620302?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Irinotecan (DRUG), Bcl-XL Proteolysis Targeting Chimera DT2216 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06620302?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06620302 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.