DT2216 + Irinotecan for Cancer

Recruiting at 2 trial locations

Overseen By Children's Oncology Group

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Children's Oncology Group

Must not be taking: CYP3A4 inducers/inhibitors

Disqualifiers: Pregnancy, Lymphoma, Uncontrolled infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

81 Participants Needed

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

I am between 1 and 21 years old.

I am between 1 and 39 years old.

I have a solid tumor that has come back or didn't respond to treatment, but it's not in my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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).

24 months

Multiple visits per cycle for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.

60 months

Regular follow-up visits

Treatment Details

Interventions

• DT2216
• Irinotecan

Trial Overview The trial tests the safety and effectiveness of DT2216 combined with irinotecan in treating relapsed/refractory solid tumors and fibrolamellar carcinoma. DT2216 targets a protein essential for tumor cell survival, while irinotecan inhibits enzymes needed for DNA repair in cells.

Participant Groups

Group I: Treatment (DT2216, irinotecan) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+