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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

1 Year - 39 Years

Healthy Volunteers

Not accepted

Interventions

• Bcl-XL Proteolysis Targeting Chimera DT2216 — BIOLOGICAL
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Irinotecan — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Jun 12, 2025

Status verified

Jul 2025

Primary completion

Dec 30, 2031

Completion

Dec 30, 2031

Study Design

Enrollment

81 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (DT2216, irinotecan)
  Patients receive DT2216 IV over 30 minutes on days 1, 4, 8, 11, 15, and 18 of each cycle and irinotecan IV over 90 minutes on days 2-6 of cycle 1, and on days 1-5 of remaining cycles. Cycles repeat every 21 days for up to 35 cycles (24 months) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the trial.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 30 days after last dose of study drug ]

Locations (21)

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