NCT06789913Phase 2Recruiting

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)

Study sponsor: Relay Therapeutics, Inc. · RLAY

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2031-07Estimated

Enrollment · participants277Estimated

Source updated2026-08-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

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

Treatments or interventions studied

RLY-2608Drug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Parts 1 and 2: Determination of a recommended phase 2 dose RP2D(s) for Groups 1, 2, and 3; timeFrame: Cycle 1 of treatment and at the end of every cycle until study discontinuation; measure: Parts 1 and 2: Occurrence/frequency of Adverse Events (AEs), changes in vital signs, ECGs, and safety laboratory tests and their relationship to the study drugs (safety and tolerability).; timeFrame: Cycle 1 of treatment and at the end of every cycle until study discontinuation; measure: Part 3: Percentage of participants with volumetric Response.; timeFrame: Baseline, Week 24

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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