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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 27, 2025

Primary Completion Date

November 1, 2028

Study Completion Date

September 1, 2029

Conditions

SarcomaSarcoma, EwingDesmoplastic Small Round Cell TumorRefractory SarcomaOsteosarcomaRhabdomyosarcoma

Interventions

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.

Trial Locations (3)

NOT_YET_RECRUITING

Boston Children's Hospital, Boston

RECRUITING

Dana-Farber Cancer Institute, Boston

NOT_YET_RECRUITING

Brigham and Women's Hospital, Boston