PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors (NCT06721689) | Clinical Trial Compass
RecruitingPhase 1/2
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
United States59 participantsStarted 2025-03-23
Plain-language summary
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.
Who can participate
Age range1 Year – 30 Years
SexALL
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Inclusion criteria
✓. Age:
✓. Diagnosis of:
✓. Disease status:
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 (age greater than 16 years) or Lansky Performance Status of at least 60 (age less than 16 years).
✓. Females of childbearing potential must have a negative urine/serum pregnancy test.
✓. Adequate bone marrow function
✓. Adequate renal function as evidenced by creatinine clearance as calculated by the Schwartz equation (see below), radioisotope glomerular filtration rate (GFR) greater than or equal to 70 mL/min/1.73 m2, or maximum serum creatinine as below:
✓. Adequate liver function
Exclusion criteria
✕. 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.
✕. Pregnant or lactating females.
✕
What they're measuring
1
Phase 1A and Phase 1B: Number of participants who experience a dose limiting toxicity (DLT)
Timeframe: 1 month
2
Phase 2 Neuroblastoma Cohort (NBL): Number of paricptants who achieve a complete response (CR), partial response (PR), or minor response (MR)
Timeframe: 2 years
3
Phase 2 Rhabdomyosarcoma (RMS) Cohort: Number of participants who achieve a complete response (CR) or partial response (PR)