ClinicaliQ Trial Snapshot
- A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation — Recruiting • Phase II • Cardiology / Cardiovascular • NCT06789913.
- What is being tested: RLY-2608, a mutant-selective PI3Kα inhibitor, is being evaluated for safety and efficacy in treating PIK3CA-related overgrowth spectrum (PROS) and PIK3CA-driven malformations across a Phase 2 randomized study design.
- Patient eligibility overview: The trial enrolls both adults and children with confirmed PIK3CA mutations causing overgrowth disorders and associated malformations, representing a genetically-defined patient population with a rare developmental condition.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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 Snapshot
- Key Inclusion Criteria: * The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification. * One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and/or cell-free DNA from the lesion or blood. Some participants may be eligible without a documented PIK3CA mutation as long as no other genetic driver has been documented. * Lansky (
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.