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) (NCT06789913)

🧪 Interventions in This Study

• RLY-2608 (DRUG)
• Placebo (DRUG)

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (40 Sites)

Showing the first 25 of 40 sites.

• Phoenix Children's Hospital — Phoenix, Arizona
• Arkansas Children's Hospital — Little Rock, Arkansas
• University of California, Los Angeles — Los Angeles, California
• Stanford University — Palo Alto, California
• University of California, San Francisco — San Francisco, California
• Children's Hospital Colorado — Aurora, Colorado
• Children's Hospital of Atlanta — Atlanta, Georgia
• Riley Children's Hospital — Indianapolis, Indiana
• University of Iowa — Iowa City, Iowa
• Johns Hopkins Medical Institute — Baltimore, Maryland
• Boston Children's Hospital — Boston, Massachusetts
• Corewell Health — Grand Rapids, Michigan
• Mayo Clinic — Rochester, Minnesota
• Washington University School of Medicine — St Louis, Missouri
• NYU Langone Health — New York, New York
• UNC Chapel Hill — Chapel Hill, North Carolina
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
• Cleveland Clinic Children's — Cleveland, Ohio
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
• Texas Children's Hospital — Houston, Texas
• Seattle Children's Hospital — Seattle, Washington
• University of Wisconsin, Madison — Madison, Wisconsin
• Sydney Children's Hospital, Randwick — Randwick, New South Wales
• Children's Health Queensland Hospital and Health — South Brisbane, Queensland
• Monash Health — Clayton, Victoria

📞 Contact the Study Coordinator

Phone: (617) 322-0731

Email: ClinicalTrials@relaytx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in PIK3CA-Related Overgrowth Spectrum (PROS)

• Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1) — Boston, Massachusetts
• Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum — San Francisco, California
• EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS) — St Louis, Missouri

Explore by condition: All PIK3CA-Related Overgrowth Spectrum (PROS) clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.