Trials / Recruiting
RecruitingNCT06789913
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 277 (estimated)
- Sponsor
- Relay Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, RLY-2608, in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations driven by PIK3CA mutation. Part 1 is a dose selection, Part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and Part 3 is randomized, double-blinded study vs placebo.
Conditions
- PIK3CA-Related Overgrowth Spectrum (PROS)
- Lymphatic Malformations
- Vascular Malformations
- PIK3CA Mutation
- CLOVES Syndrome
- Klippel Trenaunay Syndrome
- Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RLY-2608 | RLY-2608 is a mutant-selective, oral PI3Kα inhibitor. |
| DRUG | Placebo | RLY-2608 matched-placebo |
Timeline
- Start date
- 2025-06-13
- Primary completion
- 2031-07-01
- Completion
- 2031-10-01
- First posted
- 2025-01-23
- Last updated
- 2026-01-08
Locations
25 sites across 6 countries: United States, Australia, Belgium, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06789913. Inclusion in this directory is not an endorsement.