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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 (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 (The ReInspire Study)

NCT06789913

RecruitingPhase 2

Sponsor: Relay Therapeutics, Inc.

Conditions: PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation, CLOVES Syndrome

Interventions: RLY-2608, Placebo

Countries: United States, Australia, Belgium, France, Germany, Ireland, Italy, Spain

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 overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification.
* One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and/or cell-free DNA from the lesion or blood. Some participants may be eligible without a documented PIK3CA mutation, with the sponsor's approval, as long as no other genetic driver has been documented.
* Lansky (\<16 yo) or Karnofsky (≥16 yo) performance status of ≥50.
* Agree to provide archived lesional fluid and/or tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess PIK3CA status.

Key Exclusion Criteria:

* Known hypersensitivity to RLY-2608.
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
* Clinically significant, uncontrolled cardiovascular disease
* Received disease-directed therapy prior to the first dose of study drug:

  1. Systemic therapy or antibody within 5 half-lives of the therapy.
  2. Local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.
Locations (40)
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Grand Rapids, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Madison, Wisconsin, United States
  • Randwick, New South Wales, Australia
  • South Brisbane, Queensland, Australia
  • Clayton, Victoria, Australia
  • Parkville, Victoria, Australia
  • Parkville, Victoria, Australia
  • Ottignies-Louvain-la-Neuve, Belgium
  • Paris, France
  • Halle, Germany
  • + 10 more on CT.gov