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Phase 2 Study of RLY-2608 for PIK3CA-Related Overgrowth and Malformations

This Phase 2 study, called ReInspire, is testing a drug called RLY-2608 for adults and children with PIK3CA-Related Overgrowth Spectrum (PROS) and other malformations caused by a specific genetic change (PIK3CA mutation). RLY-2608 is designed to target this specific mutation. The study aims to find the best dose of RLY-2608 and see how safe and effective it is. Success will be measured by how much the affected areas shrink. To join, you must have a clinical diagnosis of PROS or a related malformation, and a documented PIK3CA mutation. The study plans to enroll 277 participants, but its current status is unclear.

Study design
This is a Phase 2, randomized study with 277 planned participants. It has three parts: dose selection, exploring different groups, and a randomized, double-blinded comparison against a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures safety and tolerability at the end of every treatment cycle until discontinuation, and volumetric response at Baseline and Week 24.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06789913

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)

Recruiting
PHASE2Ages 2+InterventionalTreatment
Relay Therapeutics, Inc.
~277 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:RLY-2608Placebo

At a glance

Recruiting sites
40 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts 1 and 2: Determination of a recommended phase 2 dose RP2D(s) for Groups 1, 2, and 3
Measured over Cycle 1 of treatment and at the end of every cycle until study discontinuation
+2 more outcomes measured

Conditions

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

Explore related trials

Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, and Skeletal/Spinal Abnormalities SyndromeKlippel Trenaunay syndromeLymphatic malformationMegalencephaly capillary malformationPIK3CA-Related Overgrowth SpectrumVascular malformationPIK3CA Gene

Where it's being run

40 sites across 29 states
Italy4
California3
Victoria3
Spain3
Ohio2
United Kingdom2
Arizona1
Arkansas1

Who to contact

Relay Therapeutics, Inc
[email protected]
617-322-0731
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Eligibility criteria

Inclusion

The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification.
One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and/or cell-free DNA from the lesion or blood. Some participants may be eligible without a documented PIK3CA mutation, with the sponsor's approval, as long as no other genetic driver has been documented.
Lansky (\<16 yo) or Karnofsky (≥16 yo) performance status of ≥50.
Agree to provide archived lesional fluid and/or tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess PIK3CA status.

Exclusion

Known hypersensitivity to RLY-2608.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
Clinically significant, uncontrolled cardiovascular disease
Received disease-directed therapy prior to the first dose of study drug:

What this trial measures

  • Parts 1 and 2: Determination of a recommended phase 2 dose RP2D(s) for Groups 1, 2, and 3Cycle 1 of treatment and at the end of every cycle until study discontinuation
  • 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).Cycle 1 of treatment and at the end of every cycle until study discontinuation
  • Part 3: Percentage of participants with volumetric Response.Baseline, Week 24