drugset / Trial / NCT06721689
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Phase 1/2
Recruiting
59 enrolled
Theodore Laetsch
Peel Therapeutics Inc · collabUniversity of Pennsylvania · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-03-23
- Primary completion
- 2030-04
- Completion
- 2031-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEEL-224 | Unknown | — | — |
| Subject | Temozolomide | Small molecule | — | — |
| Subject | Vincristine | Small molecule | — | — |