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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)

Exploring RLY-2608 for PIK3CA mutations in growth-related conditions.

Recruiting
2 years and older
All
Phase 2

This study is testing a medicine called zovegalisib (RLY-2608) for people with a condition called PIK3CA Related Overgrowth Spectrum (PROS). PROS happens when a gene called PIK3CA has a change, causing too much growth in parts of the body. The study has three parts: the first part finds the right dose, the second part looks at different groups, and the third part tests the medicine against a placebo (a pill with no medicine).

Key points:

  • The study involves multiple visits and may require a biopsy (a small tissue sample) from the affected area.
  • Participants must have PROS or a similar condition and may need to prove a specific gene change in their body.
  • If you have heart problems or allergies to the medicine, you may not be able to join.

Participants will be checked to see if they can join based on their health and past treatments. They should not have received certain treatments too close to the study start. The study aims to find a safe and effective way to help those with PROS. Always talk to your doctor before joining a study.

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

NCT06789913

Relay Therapeutics, Inc.

17 October 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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