First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer (NCT05216432)
🩺 Plain-English Summary (8th-Grade Level)
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors. It will also evaluate RLY-2608 in combination RLY-2608 + fulvestrant and in triple combination RLY-2608 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) or CDK4 inhibitor (PF-07220060) for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2).
Who can join: Review the eligibility criteria below.
Location: The University of Arizona Cancer Center — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- The University of Arizona Cancer Center — Tucson, Arizona
- University of California-San Diego — San Diego, California
- HealthONE — Denver, Colorado
- Yale University — New Haven, Connecticut
- Florida Cancer Specialists — Orlando, Florida
- Boca Raton Clinical Research (BRCR) Global — Plantation, Florida
- University of Chicago Medical Center — Chicago, Illinois
- Community Health Network — Indianapolis, Indiana
- Massachusetts General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Washington University School of Medicine St. Louis — St Louis, Missouri
- Renown Regional Medical Center — Reno, Nevada
- Rutgers University — New Brunswick, New Jersey
- NYU Langone — New York, New York
- Columbia University Herbert Irving Comprehensive Cancer Center — New York, New York
- Memorial Sloan Kettering — New York, New York
- Tennessee Oncology — Nashville, Tennessee
- University of Texas Southwestern Medical Center — Dallas, Texas
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas
- University of Utah- Huntsman Cancer Center — Salt Lake City, Utah
- Inova Schar Cancer Center — Fairfax, Virginia
- NEXT Virginia — Fairfax, Virginia
- UW Carbone Cancer Center — Madison, Wisconsin
- St Vincents Hospital — Sydney, New South Wales
📞 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.