New drug targets root cause of rare overgrowth syndromes
NCT ID NCT06789913
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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A.O.U Città della Salute e della Scienza di Torino
RECRUITINGTorino, Italy
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Arkansas Children's Hospital
RECRUITINGLittle Rock, Arkansas, 72202, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Chelsea and Westminster Hospital
RECRUITINGLondon, SW10 9NH, United Kingdom
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Children's Health Queensland Hospital and Health
RECRUITINGSouth Brisbane, Queensland, 4101, Australia
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Children's Hospital Colorado
RECRUITINGAurora, Colorado, 80045, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Children's Hospital of Atlanta
RECRUITINGAtlanta, Georgia, 30329, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Cleveland Clinic Children's
RECRUITINGCleveland, Ohio, 44195, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Corewell Health
RECRUITINGGrand Rapids, Michigan, 49503, United States
Contact Email: •••••@•••••
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Great Ormond Street Hospital for Children
RECRUITINGLondon, United Kingdom
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Sant Joan de Deu
RECRUITINGBarcelona, Spain
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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Hospital Universitario A Coruña
RECRUITINGA Coruña, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital Universitario La Paz
RECRUITINGMadrid, Spain
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Johns Hopkins Medical Institute
RECRUITINGBaltimore, Maryland, 21287, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Monash Health
RECRUITINGClayton, Victoria, 3168, Australia
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Murdoch Children's Research Institute
RECRUITINGParkville, Victoria, 3052, Australia
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Ospedale Pediatrico Bambino Gesù IRCCS
RECRUITINGRoma, Italy
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Phoenix Children's Hospital
RECRUITINGPhoenix, Arizona, 85016, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Riley Children's Hospital
RECRUITINGIndianapolis, Indiana, 46202, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Royal Melbourne Hospital
RECRUITINGParkville, Victoria, 3050, Australia
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Seattle Children's Hospital
RECRUITINGSeattle, Washington, 98101, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Stanford University
RECRUITINGPalo Alto, California, 94304, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Sydney Children's Hospital, Randwick
RECRUITINGRandwick, New South Wales, 2031, Australia
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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UC Louvain
RECRUITINGOttignies-Louvain-la-Neuve, Belgium
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
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UNC Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27599, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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University of California, Los Angeles
RECRUITINGLos Angeles, California, 90095, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94158, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Email: •••••@•••••
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University of Halle
RECRUITINGHalle, Germany, Germany
Contact Phone: •••-•••-•••• Email: •••••@•••••
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University of Wisconsin, Madison
RECRUITINGMadison, Wisconsin, 53715, United States
Contact Email: •••••@•••••
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
Contact Email: •••••@•••••