PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

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.

Trial Details

NCT ID

NCT06721689

Phase

PHASE1 / PHASE2

Sponsor

Theodore Laetsch

Status

RECRUITING

Cancer Type

Sarcoma

Interventions

PEEL-224
Vincristine
Temozolomide (TMZ)

Locations (sample)

Los Angeles, California, United States|34.05223,-118.24368
San Francisco, California, United States|37.77493,-122.41942
Boston, Massachusetts, United States|42.35843,-71.05977
Boston, Massachusetts, United States|42.35843,-71.05977
Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

Phase 1: Age greater than or equal to 1 year and less than or equal to18 years
Phase 2 Neuroblastoma (NBL) cohort: Age greater than or equal to 1 year and less than or equal to 30 years
Phase 2 Rhabdomyosarcoma (RMS) cohort: Age greater than or equal to 1 year and less than or equal to18 years
Diagnosis of:

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