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New drug targets root cause of rare overgrowth syndromes

NCT ID NCT06789913

Disease control Sponsor: Relay Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 26, 2026 · Updated 5 times

Summary

This Phase 2 study tests an oral drug called RLY-2608 in adults and children with overgrowth conditions (like CLOVES or Klippel-Trenaunay syndrome) caused by PIK3CA gene mutations. The drug is designed to block the faulty protein driving abnormal tissue growth. The trial will enroll 277 participants to find the best dose, check safety, and see if it shrinks lesions or malformations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RLY-2608 (zovegalisib), an oral drug that targets a specific mutated protein (PI3Kα) to slow abnormal growth
What this could lead to
If successful, this could lead to a targeted treatment that shrinks overgrown tissues and malformations, improving quality of life for people with these rare conditions.
What could go wrong
This is a Phase 2 trial, so it is still early. The drug may not work for all types of overgrowth, and side effects (such as those common to PI3K inhibitors) are possible. Long-term safety and effectiveness are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 277 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

angioosteohypertrophic syndrome CLOVES syndrome Lymphatic Abnormalities lymphatic malformation megalencephaly-capillary malformation-polymicrogyria syndrome PIK3CA-related overgrowth spectrum vascular malformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cloves syndrome Klippel-Trenaunay syndrome Lymphatic malformations Megalencephaly-capillary malformation polymicrogyria syndrome (MCAP) PIK3CA mutation PIK3CA-related overgrowth spectrum (PROS) Vascular anomalies Vascular malformations

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    40 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Torino, Italy

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Chelsea and Westminster Hospital

    RECRUITING

    London, SW10 9NH, United Kingdom

  • Children's Health Ireland at Crumlin

    RECRUITING

    Dublin, D12 N512, Ireland

  • Children's Health Queensland Hospital and Health

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

    Contact Email: •••••@•••••

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic Children's

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Great Ormond Street Hospital for Children

    RECRUITING

    London, United Kingdom

  • Hospital Sant Joan de Deu

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario A Coruña

    RECRUITING

    A Coruña, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Spain

  • IRCCS Fondazione Policlinico Universitario A. Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Johns Hopkins Medical Institute

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Monash Health

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Murdoch Children's Research Institute

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Necker Hospital

    RECRUITING

    Paris, 75015, France

  • Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Ospedale Pediatrico Bambino Gesù IRCCS

    RECRUITING

    Roma, Italy

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Riley Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98101, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Sydney Children's Hospital, Randwick

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • UC Louvain

    RECRUITING

    Ottignies-Louvain-la-Neuve, Belgium

  • UNC Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Halle

    RECRUITING

    Halle, Germany, Germany

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Wisconsin, Madison

    RECRUITING

    Madison, Wisconsin, 53715, United States

    Contact Email: •••••@•••••

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

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