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)
← catalyst calendarNCT06789913 · readout ≤ 1,807 d
Sponsored by Relay Therapeutics, Inc. (industry) · RLAY — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
277estimated
Sites
40
Countries
Australia, Belgium, France +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-13 | actual | When the study began enrolling |
| Primary completion | Jul 2031 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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
Interventions
- Drug: RLY-2608
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFParts 1 and 2: Determination of a recommended phase 2 dose RP2D(s) for Groups 1, 2, and 3
measured Cycle 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).
measured Cycle 1 of treatment and at the end of every cycle until study discontinuation
Part 3: Percentage of participants with volumetric Response.
measured Baseline, Week 24
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