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

NCT06620302 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-05-05

No results posted yet for this 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

  • 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

Interventions

BIOLOGICAL

Bcl-XL Proteolysis Targeting Chimera DT2216

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Irinotecan

Given IV

Sponsors & Collaborators

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Michael V Ortiz · Pediatric Early Phase Clinical Trial Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2031-12-30
Completion
2031-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06620302 on ClinicalTrials.gov