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RecruitingPhase 2

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)

Relay Therapeutics, Inc. · NCT06789913

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
277
US sites recruiting
22
Study start
June 13, 2025
Record last updated
August 25, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: RLY-2608; Placebo

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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:
  • Systemic therapy or antibody within 5 half-lives of the therapy.
  • Local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.

Recruiting US locations

  • Phoenix Children's Hospital

    Phoenix, AZ 85016

    Site contact: Chris Oless · 602-933-0188 · dg_EDDT@phoenixchildrens.com

  • Arkansas Children's Hospital

    Little Rock, AR 72202

    Site contact: D'Ann Pierce · 501-364-4440 · PierceCarolD@uams.edu

  • University of California, Los Angeles

    Los Angeles, CA 90095

    Site contact: Brianna Connors · 310-825-6708 · bconnors@mednet.ucla.edu

  • Stanford University

    Palo Alto, CA 94304

    Site contact: Ramrada Lekwuttikarn · 650-313-8207 · ramrada1@stanford.edu

  • University of California, San Francisco

    San Francisco, CA 94158

    Site contact: Beth Winger, MD · Beth.Winger@ucsf.edu

  • Children's Hospital Colorado

    Aurora, CO 80045

    Site contact: Taizo Nakano, MD · 720-777-6663 · taizo.nakano@childrenscolorado.org

  • Children's Hospital of Atlanta

    Atlanta, GA 30329

    Site contact: Lauren Rogers · 404-785-2727 · Lauren.Rogers@choa.org

  • Riley Children's Hospital

    Indianapolis, IN 46202

    Site contact: Riley PHOS Research Team · 317-948-8540 · rileyphosresearchteam@iuhealth.org

  • University of Iowa

    Iowa City, IA 52242

    Site contact: Maureen Austin · 319-356-0378 · Maureen-Austin@uiowa.edu

  • Johns Hopkins Medical Institute

    Baltimore, MD 21287

    Site contact: Alex Thompson · 410-955-5734 · athomp43@jhmi.edu

  • Boston Children's Hospital

    Boston, MA 02115

    Site contact: Vascular Anomalies Center · 617-355-5226 · vascular@childrens.harvard.edu

  • Corewell Health

    Grand Rapids, MI 49503

    Site contact: Amanda Bartolovic · Amanda.bartolovic@corewellhealth.org

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Mary Manyara · 507-266-3212 · Manyara.mary@mayo.edu

  • Washington University School of Medicine

    St Louis, MO 63110

    Site contact: Allison Barnwell · pedshemonctrialreferral@wustl.edu

  • NYU Langone Health

    New York, NY 10016

  • UNC Chapel Hill

    Chapel Hill, NC 27599

    Site contact: Miriam Davis · 919-966-2333 · miriam.davis@unc.edu

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, OH 45229

    Site contact: Lexie Price · 513- 803-0226 · Sarah.price@cchmc.org

  • Cleveland Clinic Children's

    Cleveland, OH 44195

    Site contact: Ana Beatriz Ferreira Alves · 216-636-1926 · ferreia2@ccf.org

  • Children's Hospital of Philadelphia

    Philadelphia, PA 19104

    Site contact: Melissa Casey · 267-426-9188 · caseyma@chop.edu

  • Texas Children's Hospital

    Houston, TX 77030

    Site contact: Gaylon Stevenson · 832-824-1518 · gnsteve1@texaschildrens.org

  • Seattle Children's Hospital

    Seattle, WA 98101

    Site contact: Whitney Eng · 206-884-4626 · Whitney.Eng@seattlechildrens.org

  • University of Wisconsin, Madison

    Madison, WI 53715

    Site contact: Department of Dermatology · info@clinicaltrials.wisc.edu

Study contacts (from the official record)

  • Relay Therapeutics, Inc · 617-322-0731 · ClinicalTrials@relaytx.com
A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in… (NCT06789913) | Bored Studies