RecruitingPhase 1Phase 2NCT06620302

Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma

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

Enrollment

81 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 1 YearMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing DT2216 — a drug designed to destroy a protein called BCL-XL that helps cancer cells survive — in combination with standard chemotherapy for children, adolescents, and young adults with solid tumors or a rare liver cancer called fibrolamellar carcinoma (FLC) that has come back or stopped responding to prior treatment. **You may be eligible if...** - Phase 1: You are between 1 and 21 years old with a relapsed or refractory solid tumor (not a brain tumor) - Phase 2: You are between 1 and 39 years old and have fibrolamellar carcinoma (FLC) confirmed by a specific genetic test (DNAJB1:PRKACA fusion) - Your disease is measurable or detectable - For Phase 1: there is no known curative therapy available for your current condition - Your organ function meets the required study standards **You may NOT be eligible if...** - Phase 1: you have a primary central nervous system tumor - Phase 2: you do not have genomically confirmed FLC - Your organ function does not meet the required levels - You have active infections or other conditions that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBcl-XL Proteolysis Targeting Chimera DT2216

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGIrinotecan

Given IV

Locations(21)

Children's Hospital of Alabama

Birmingham, Alabama, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06620302

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