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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

Study of RLY-2608 for PIK3CA-related growth and malformations.

Recruiting
2 years and older
All
Phase 2

This study is testing a new drug called RLY-2608, which targets a specific gene mutation called PIK3CA. This mutation can cause overgrowth and other problems in the body. The study has three parts: the first part finds the right dose; the second part examines different groups of people to see how they respond; and the third part compares the drug to a placebo (a pill with no medicine).

Key Points:

  • Participants should be diagnosed with a condition related to the PIK3CA mutation.
  • Some medical history or conditions may exclude you from participating.
  • Participation may involve providing tissue samples or blood for testing.

To join, you must have a PIK3CA mutation or similar issues, and be willing to provide tissue samples if needed. You can’t join if you have had certain treatments recently or have heart issues.

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

NCT06789913

Relay Therapeutics, Inc.

7 March 2026

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What is a clinical trial?

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

Why should I take part in a clinical trial?

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

How long does a clinical trial take place?

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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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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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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