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)

ClinicalTrials.gov ID: NCT06789913

Public ClinicalTrials.gov record NCT06789913. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (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.

Study identification

NCT ID: NCT06789913
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Relay Therapeutics, Inc.; Industry
Enrollment: 277 participants

Conditions and interventions

Conditions

Interventions

RLY-2608 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 2 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 12, 2025
Primary completion: Jun 30, 2031
Completion: Sep 30, 2031
Last update posted: Aug 24, 2026

2025 – 2031

United States locations

U.S. sites: 22
U.S. states: 19
U.S. cities: 22

Facility	City	State	ZIP	Site status
Phoenix Children's Hospital	Phoenix	Arizona	85016	Recruiting
Arkansas Children's Hospital	Little Rock	Arkansas	72202	Recruiting
University of California, Los Angeles	Los Angeles	California	90095	Recruiting
Stanford University	Palo Alto	California	94304	Recruiting
University of California, San Francisco	San Francisco	California	94158	Recruiting
Children's Hospital Colorado	Aurora	Colorado	80045	Recruiting
Children's Hospital of Atlanta	Atlanta	Georgia	30329	Recruiting
Riley Children's Hospital	Indianapolis	Indiana	46202	Recruiting
University of Iowa	Iowa City	Iowa	52242	Recruiting
Johns Hopkins Medical Institute	Baltimore	Maryland	21287	Recruiting
Boston Children's Hospital	Boston	Massachusetts	02115	Recruiting
Corewell Health	Grand Rapids	Michigan	49503	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting
UNC Chapel Hill	Chapel Hill	North Carolina	27599	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Cleveland Clinic Children's	Cleveland	Ohio	44195	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
Texas Children's Hospital	Houston	Texas	77030	Recruiting
Seattle Children's Hospital	Seattle	Washington	98101	Recruiting
University of Wisconsin, Madison	Madison	Wisconsin	53715	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06789913, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 24, 2026 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06789913 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →