clinical trial · NCT06789913
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 (The ReInspire Study)
PIK3CA-Related Overgrowth Spectrum (PROS)Lymphatic MalformationsVascular MalformationsPIK3CA MutationCLOVES SyndromeKlippel Trenaunay SyndromeMegalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)Vascular AnomaliesRLY-2608Placebo
brief summary
This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (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.
started
Jun 13, 2025
primary completion
Jul 1, 2031
completion
Oct 1, 2031
last updated
Jun 12, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol