PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
A Phase 1/2 Clinical Trial of the Novel Topoisomerase I Inhibitor PEEL-224 as a Single Agent and in Combination With Vincristine and Temozolomide in Children With Refractory, Progressive or Relapsed Solid Tumors
Theodore Laetsch
59 participants
Mar 23, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
PEEL-224 (PEG-\[SN22\]4) is a novel topoisomerase I inhibitor
Vincristine is an inhibitor of microtubular formation which is approved by the Food and Drug Administration (FDA) and is commercially available.
Temozolomide is an alkylating agent which is approved by the FDA and is commercially available.
Locations(7)
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NCT06721689