DT2216 + Irinotecan for Cancer
Trial Summary
What is the purpose of this trial?
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.
Research Team
Michael V Ortiz
Principal Investigator
Pediatric Early Phase Clinical Trial Network
Eligibility Criteria
This trial is for children, adolescents, and young adults with solid tumors or fibrolamellar cancer that has relapsed or is refractory. Ages eligible vary: 1-21 years for Phase I and 1-39 years for Phase II. Participants need measurable disease (Phase II) or evaluable disease (Phase I), except primary central nervous system tumors. They must have an acceptable performance status based on ECOG scores.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DT2216 and irinotecan intravenously in cycles, with DT2216 administered on days 1, 4, 8, 11, 15, and 18, and irinotecan 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).
Follow-up
Participants are monitored for safety and effectiveness after treatment completion at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.
Treatment Details
Interventions
- DT2216
- Irinotecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor