PEEL-224 + Vincristine + Temozolomide for Pediatric Cancer

(PEEL-224 Trial)

Overseen By James Robinson, MSW, MPH

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Theodore Laetsch

Must not be taking: Anti-cancer agents

Disqualifiers: CNS tumors, Transplantation, HIV, others

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

Compensation: Varies

Number of Visits: 3

59 Participants Needed

Trial Summary

What is the purpose of this trial?

The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide.

Research Team

Jacquelyn Crane, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for children with specific types of cancer that have not responded to previous treatments or have come back after treatment. These cancers include neuroblastoma and rhabdomyosarcoma, which are serious conditions affecting nerve cells and muscles.

Inclusion Criteria

My cancer can be measured or evaluated by medical tests.

Parental/guardian permission and child assent

I am not pregnant.

Exclusion Criteria

Pregnant or lactating females

I am not using any other cancer treatments.

I have previously been treated with PEEL-224.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1A Treatment

Participants receive PEEL-224 as a single agent to test safety, tolerability, and PK profile

21-day cycles, up to 24 cycles (approximately 18 months)

Visits on days 1 and 8 of each cycle

Phase 1B Treatment

Participants receive PEEL-224 in combination with vincristine and temozolomide to test safety, tolerability, and PK profile

21-day cycles, up to 24 cycles (approximately 18 months)

Visits on days 1 and 8 of each cycle

Phase 2 Treatment

Participants receive the RP2D of PEEL-224 in combination with vincristine and temozolomide to estimate objective response rate

21-day cycles, up to 24 cycles (approximately 18 months)

Visits on days 1 and 8 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after last dose

Treatment Details

Interventions

• PEEL-224
• Temozolomide
• Vincristine

Trial Overview The study is testing PEEL-224 alone (phase 1A) and combined with vincristine and temozolomide (phase 1B). The goal is to find the safest dose for kids (phase 1) and then see how well it works at that dose in shrinking their tumors (phase 2).

Participant Groups

Group I: PEEL-224, Vincristine, and Temozolomide Experimental Treatment 3 Interventions

Phase 1B will test the safety, tolerability and pharmacokinetic profile of PEEL-224 in combination with vincristine and temozolomide in pediatric subjects with refractory, progressive and relapsed solid tumors. Phase 2 will preliminary evaluate the activity profile of PEEL-224 in combination with vincristine and temozolomide in pediatric patients with refractory, progressive and relapsed NBL and RMS.

Group II: PEEL-224 Experimental Treatment 1 Intervention

Phase 1A will test the safety, tolerability and PK profile of PEEL-224 as a single agent in pediatric patients with refractory, progressive and relapsed solid tumors.

Who Is Running the Clinical Trial?

Theodore Laetsch

Lead Sponsor

Trials

4

Recruited

80+

Peel Therapeutics Inc

Industry Sponsor

Trials

3

Recruited

160+