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Study identifier: NCT06620302 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Childhood Fibrolamellar Carcinoma · Recurrent Childhood Fibrolamellar Carcinoma · Recurrent Childhood Malignant Solid Neoplasm  ·  Sponsor: Children's Oncology Group

PhasePhase 1/Phase 2
Planned participants81
Who can joinAll sexes, 1 Year to 39 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (21)

Children's Hospital of AlabamaBirmingham, Alabama, United StatesRecruiting
Children's Hospital Los AngelesLos Angeles, California, United StatesRecruiting
Children's Hospital of Orange CountyOrange, California, United StatesRecruiting
UCSF Medical Center-Mission BaySan Francisco, California, United StatesRecruiting
Children's Hospital ColoradoAurora, Colorado, United StatesRecruiting
Children's National Medical CenterWashington D.C., District of Columbia, United StatesRecruiting
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, Georgia, United StatesRecruiting
Lurie Children's Hospital-ChicagoChicago, Illinois, United StatesRecruiting
Riley Hospital for ChildrenIndianapolis, Indiana, United StatesRecruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting
C S Mott Children's HospitalAnn Arbor, Michigan, United StatesRecruiting
University of Minnesota/Masonic Cancer CenterMinneapolis, Minnesota, United StatesRecruiting

+ 9 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06620302