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NCT06789913 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Klippel-Trenaunay Syndrome and PIK3CA-related Overgrowth Spectrum (PROS), sponsored by Relay Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 277
- Enrollment target
- 20
- Study locations
NCT06789913: Recruiting Phase 2 study of Klippel-Trenaunay Syndrome and PIK3CA-related Overgrowth Spectrum (PROS), sponsored by Relay Therapeutics.
NCT06789913 is a Phase 2 study of Klippel-Trenaunay Syndrome and PIK3CA-related Overgrowth Spectrum (PROS) that is actively recruiting participants, run by Relay Therapeutics. The registered enrollment target is 277 participants, below the 677-participant average among 3 other Klippel-Trenaunay Syndrome trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06789913, a Phase 2 study of Klippel-Trenaunay Syndrome and PIK3CA-related Overgrowth Spectrum (PROS), is actively recruiting participants, sponsored by Relay Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 277 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG RLY-2608
Study Locations (20)
California
- University of California, Los Angeles - Los Angeles
- Stanford University - Palo Alto
- University of California, San Francisco - San Francisco
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic Children's - Cleveland
Victoria
- Monash Health - Clayton
- Murdoch Children's Research Institute - Parkville
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Georgia
- Children's Hospital of Atlanta - Atlanta
Indiana
- Riley Children's Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2025-06-13 |
| Est. Completion | 2031-10 |
| Phase | Phase 2 |
What NCT06789913 shows while recruiting
NCT06789913 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, below the 677-participant average among 3 other Klippel-Trenaunay Syndrome trials with a reported enrollment target (59% lower).
The record links to 7 conditions, with Klippel-Trenaunay Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06789913 names 20 study sites across 16 states, led by California, Ohio, Victoria.
Frequently Asked Questions
What is clinical trial NCT06789913 about?
NCT06789913 is a clinical study titled "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". 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 wit...
What is the current status of trial NCT06789913?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 277 participants. The study started on 2025-06-13. Estimated completion is 2031-10.
What conditions does trial NCT06789913 study?
This clinical trial studies the following conditions: Klippel-Trenaunay Syndrome, PIK3CA-related Overgrowth Spectrum (PROS), PIK3CA Mutation, CLOVES Syndrome, Lymphatic Malformations.
What interventions are being tested in trial NCT06789913?
The interventions under investigation include: Placebo (DRUG), RLY-2608 (DRUG).
Who is sponsoring clinical trial NCT06789913?
This trial is sponsored by Relay Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06789913 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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