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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: Recruiting Phase 1 study of Refractory Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, sponsored by Children's Oncology Group.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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

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

FieldValue
Enrollment Target 81 participants
Start Date 2025-06-12
Est. Completion 2031-12-30
Phase Phase 1
Children's Oncology Group

342 total trials

What NCT06620302 shows while recruiting

NCT06620302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 63-participant average among 59 other Refractory Malignant Solid Neoplasm trials with a reported enrollment target (29% higher).

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 names 20 study sites across 17 states, led by 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.

Learn More About Clinical Trials

Similar trials for Refractory Malignant Solid Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06620302's enrollment target sits among peer trials

81 8th of 59 higher than 52 of 59 other Refractory Malignant Solid Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06620302

Source: ClinicalTrials.gov NCT06620302, the US trial registry maintained by the National Library of Medicine. NCT06620302 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.