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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
Sponsor: Relay Therapeutics, Inc.
Summary
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.
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
277
Start Date
2025-06-13
Completion Date
2031-10
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Interventions
RLY-2608
RLY-2608 is a mutant-selective, oral PI3Kα inhibitor.
Placebo
RLY-2608 matched-placebo
Locations (25)
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's Hospital of Atlanta
Atlanta, Georgia, United States
Riley Children's Hospital
Indianapolis, Indiana, United States
Johns Hopkins Medical Institute
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Children's
Cleveland, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
University of Wisconsin, Madison
Madison, Wisconsin, United States
Sydney Children's Hospital, Randwick
Randwick, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Murdoch Children's Research Institute
Parkville, Victoria, Australia
UC Louvain
Ottignies-Louvain-la-Neuve, Belgium
Ospedale Pediatrico Bambino Gesù IRCCS
Roma, Italy
Hospital Sant Joan de Deu
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Great Ormond Street Hospital for Children
London, United Kingdom