drugset / Trial / NCT06709495
Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas
Non-randomizedSequentialOpen-labelTreatment
Summary
This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas. The names of the study drugs and biological agents involved in this study are: * PEEL-224 (a type of Topoisomerase 1 inhibitor) * Vincristine (A type of vinca alkaloid) * Temozolomide (A type of alkylating agent) * Pegfilgrastim or Filgrastim (types of Myeloid growth factors)
Timeline
- Start
- 2025-01-27
- Primary completion
- 2028-11-01
- Completion
- 2029-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEEL-224 | Unknown | — | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | Temozolomide | Small molecule | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | — |