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Clinical Trials and Novel Therapies A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, to treat PIK3CA Related Overgrowth Spectrum (PROS) and Malformations Driven by PIK3CA Mutation

<p>A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, to treat PIK3CA Related Overgrowth Spectrum (PROS) and Malformations Driven by PIK3CA Mutation</p>

Description

This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, RLY-2608, in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations driven by PIK3CA mutation. Part 1 is a dose selection, Part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and Part 3 is randomized, double-blinded study vs placebo.

Eligibility

  • Children (2 years and older), adolescents, and adults
  • Confirmed diagnosis of a PIK3CA-related overgrowth condition
  • Adequate performance status to participate in the study
  • Presence of a PIK3CA mutation

Detailed inclusion and exclusion criteria are listed at clinicaltrials.gov

Contact

Ionela Iacobas, MD

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