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)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation, CLOVES Syndrome, Klippel Trenaunay Syndrome, Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP), Vascular Anomalies
In brief
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.
Key facts
- Study ID
- NCT06789913
- Run by
- Relay Therapeutics, Inc.
- People needed
- 277
- Starts
- 2025-06-13
- Expected to finish
- 2031-10-01
- Last updated by the study team
- 2026-06-12
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
- University of California, Los Angeles — Los Angeles, California, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- University of California, San Francisco — San Francisco, California, United States (enrolling)
- Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
- Children's Hospital of Atlanta — Atlanta, Georgia, United States (enrolling)
- Riley Children's Hospital — Indianapolis, Indiana, United States (enrolling)
- Johns Hopkins Medical Institute — Baltimore, Maryland, United States (enrolling)
- Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
- Corewell Health — Grand Rapids, Michigan, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- UNC Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Cleveland Clinic Children's — Cleveland, Ohio, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Texas Children's Hospital — Houston, Texas, United States (enrolling)
- Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
- University of Wisconsin, Madison — Madison, Wisconsin, United States (enrolling)
- Sydney Children's Hospital, Randwick — Randwick, New South Wales, Australia (enrolling)
- Children's Health Queensland Hospital and Health — South Brisbane, Queensland, Australia (enrolling)
- Monash Health — Clayton, Victoria, Australia (enrolling)
- Royal Melbourne Hospital — Parkville, Victoria, Australia (enrolling)
- Murdoch Children's Research Institute — Parkville, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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