RecruitingPhase 2NCT06789913

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)

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.

Enrollment

277 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

PIK3CA Mutation Vascular Anomalies Vascular Malformations PIK3CA-Related Overgrowth Spectrum (PROS)Lymphatic Malformations CLOVES Syndrome Klippel Trenaunay Syndrome Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)

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.

Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called RLY-2608 for people with cloves syndrome, klippel trenaunay syndrome, and other related conditions. The study is currently recruiting participants at 34 locations. People eligible for this study include aged 2 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRLY-2608

RLY-2608 is a mutant-selective, oral PI3Kα inhibitor.

DRUGPlacebo

RLY-2608 matched-placebo

Locations(34)

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

Corewell Health

Grand Rapids, Michigan, 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

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

University of Wisconsin, Madison

Madison, Wisconsin, United States

Sydney Children's Hospital, Randwick

Randwick, New South Wales, Australia

Children's Health Queensland Hospital and Health

South Brisbane, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Murdoch Children's Research Institute

Parkville, Victoria, Australia

UC Louvain

Ottignies-Louvain-la-Neuve, Belgium

University of Halle

Halle, Germany

Ospedale Pediatrico Bambino Gesù IRCCS

Roma, Italy

A.O.U Città della Salute e della Scienza di Torino

Torino, Italy

Hospital Universitario A Coruña

A Coruña, Spain

Hospital Sant Joan de Deu

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Chelsea and Westminster Hospital

London, United Kingdom

Great Ormond Street Hospital for Children

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06789913

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