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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: David S Shulman, MD · Academic / Other
• Sex: All
• Age: 12 Years – 49 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is an open-label, single-arm, non-randomized, phase I/II trial 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. This is the first time that PEEL-224 will be given in combination with Vincristine and Temozolomide to humans. In Phase 1, the safety and tolerability of PEEL-224 in combination with Vincristine and Temozolomide will be assessed by dose escalation and establishment of a Recommended Phase 2 Dose. In Phase 2 the efficacy of the drug combination will be assessed in three separate cohorts of participants. The U.S. Food and Drug Administration (FDA) has not approved PEEL-224 as a treatment for Relapsed or Refractory Sarcoma. The U.S. Food and Drug Administration (FDA) has not approved Vincristine and Temozolomide for Relapsed or Refractory Sarcoma, but it has been approved for other uses. The research study procedures include screening for eligibility, study treatment in-clinic visits, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomography (PET) scans, blood tests, urine tests, and electrocardiograms (ECGs). Participants will receive study treatment for up to 34 cycles (approximately 2 years) and will be followed for up to 1 year after the last participant has received the last dose of treatment. It is expected that about 63 people will take part in this research study. PEEL Therapeutics is funding this research study by providing the study drug, PEEL-224.

Conditions

• Sarcoma
• Sarcoma, Ewing
• Desmoplastic Small Round Cell Tumor
• Refractory Sarcoma
• Osteosarcoma
• Rhabdomyosarcoma

Interventions

Type	Name	Description
DRUG	PEEL-224	Topoisomerase 1 inhibitor, 200mg amber vial, via intravenous (into the vein) infusion per protocol.
DRUG	Temozolomide	Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsule, taken orally per standard of care.
DRUG	Vincristine	Vinca alkaloid, 1 or 2mL vials, via intravenous (into the vein) infusion per institutional policy.
BIOLOGICAL	Pegfilgrastim	Myeloid growth factor administered per institutional standards.
BIOLOGICAL	Filgrastim	Myeloid growth factor administered per institutional standards.

Timeline

• Start date: 2025-01-27
• Primary completion: 2028-11-01
• Completion: 2029-09-01
• First posted: 2024-11-29
• Last updated: 2026-02-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study