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Clinical trialNCT06620302RecruitingPhase 1/PHASE2Interventional

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

SponsorChildren's Oncology GroupEnrollment81Childhood Fibrolamellar CarcinomaRecurrent Childhood Fibrolamellar CarcinomaRecurrent Childhood Malignant Solid NeoplasmRecurrent Fibrolamellar CarcinomaRecurrent Malignant Solid NeoplasmRefractory Childhood Fibrolamellar Carcinoma+3 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Children'S Hospital of Alabama

    Birmingham, Alabama, United States

    Girish Dhall
    Recruiting
  • Children'S Hospital Los Angeles

    Los Angeles, California, United States

    Fariba Navid
    Recruiting
  • Children'S Hospital of Orange County

    Orange, California, United States

    Josephine H. Haduong
    Recruiting
  • Ucsf Medical Center-Mission Bay

    San Francisco, California, United States

    Kieuhoa T. Vo
    Recruiting
  • Children'S Hospital Colorado

    Aurora, Colorado, United States

    Margaret E. Macy
    Recruiting
  • Children'S National Medical Center

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

    AeRang Kim
    Recruiting
  • Children'S Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, United States

    Jason R. Fangusaro
    Recruiting
  • Lurie Children'S Hospital-Chicago

    Chicago, Illinois, United States

    Elizabeth A. Sokol
    Recruiting
  • Riley Hospital for Children

    Indianapolis, Indiana, United States

    Brian D. Weiss
    Recruiting
  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

    Allison F. O'Neill
    Recruiting
  • C S Mott Children'S Hospital

    Ann Arbor, Michigan, United States

    Rajen Mody
    Recruiting
  • University of Minnesota/masonic Cancer Center

    Minneapolis, Minnesota, United States

    Robin L. Williams
    Recruiting
  • Washington University School of Medicine

    St Louis, Missouri, United States

    Shalini Shenoy
    Recruiting
  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Michael V. Ortiz
    Recruiting
  • Nyp/columbia University Medical Center/herbert Irving Comprehensive Cancer Center

    New York, New York, United States

    Nobuko Hijiya
    Recruiting
  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

    Joseph G. Pressey
    Recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Jacquelyn Crane
    Recruiting
  • Children'S Hospital of Pittsburgh of Upmc

    Pittsburgh, Pennsylvania, United States

    Andrew Bukowinski
    Recruiting
  • Saint Jude Children'S Research Hospital

    Memphis, Tennessee, United States

    Jessica Gartrell
    Recruiting
  • Baylor College of Medicine/dan L Duncan Comprehensive Cancer Center

    Houston, Texas, United States

    Jennifer H. Foster
    Recruiting
  • Seattle Children'S Hospital

    Seattle, Washington, United States

    Katherine G. Tarlock
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bcl-XL Proteolysis Targeting Chimera DT2216Irinotecan →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
12 Jun 2025
Primary completion
30 Dec 2031
Completion
30 Dec 2031
Last update posted
5 May 2026
Registered enrollment
81
Registry id
NCT06620302

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.