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Study identifier: NCT06789913 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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)

Condition: PIK3CA-Related Overgrowth Spectrum (PROS) · Lymphatic Malformations · Vascular Malformations  ·  Sponsor: Relay Therapeutics, Inc.

PhasePhase 2
Planned participants277
Who can joinAll sexes, 2 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Relay Therapeutics, Inc  ·  617-322-0731  ·  ClinicalTrials@relaytx.com

Always discuss trial participation with your own doctor first.

Locations (34)

Phoenix Children's HospitalPhoenix, Arizona, United StatesRecruiting
Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
University of California, Los AngelesLos Angeles, California, United StatesRecruiting
Stanford UniversityPalo Alto, California, United StatesRecruiting
University of California, San FranciscoSan Francisco, California, United StatesRecruiting
Children's Hospital ColoradoAurora, Colorado, United StatesRecruiting
Children's Hospital of AtlantaAtlanta, Georgia, United StatesRecruiting
Riley Children's HospitalIndianapolis, Indiana, United StatesRecruiting
Johns Hopkins Medical InstituteBaltimore, Maryland, United StatesRecruiting
Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting
Corewell HealthGrand Rapids, Michigan, United StatesRecruiting
Mayo ClinicRochester, Minnesota, United StatesRecruiting

+ 22 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06789913