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.
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.
+12 more
Exclusion Criteria
Pregnant or lactating females
I am not using any other cancer treatments.
I have previously been treated with PEEL-224.
+4 more
Trial 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
Participant Groups
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).
2Treatment groups
Experimental Treatment
Group I: PEEL-224, Vincristine, and TemozolomideExperimental Treatment3 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-224Experimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital of PhiladelphiaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Theodore LaetschLead Sponsor
Peel Therapeutics IncIndustry Sponsor