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.
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
Phase 1: Refractory, progressive or relapsed non-central nervous system (CNS) solid tumors who have received at least 1 line of upfront therapy. Patients must have had histologic verification of their malignancy at original diagnosis or relapse
Prior treatment with PEEL-224.
Subjects receiving any other anti-cancer agents.
Subjects with primary central nervous system (CNS) solid tumors or central nervous system (CNS) metastatic disease.
Subjects with prior allogeneic stem cell or solid organ transplantation.
Theodore Laetsch
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
Peel Therapeutics Inc
Collaborator
University of Pennsylvania
Collaborator