New drug targets root cause of rare overgrowth syndromes

NCT ID NCT06789913

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

First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 3 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.

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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

Contacts and locations

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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
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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