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
Recruiting now · Phase 1
Conditions studied: PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor
In brief
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).
Key facts
- Study ID
- NCT05216432
- Run by
- Relay Therapeutics, Inc.
- People needed
- 930
- Starts
- 2021-12-08
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2025-09-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- University of California-San Diego — San Diego, California, United States (enrolling)
- HealthONE — Denver, Colorado, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- Florida Cancer Specialists — Orlando, Florida, United States (enrolling)
- The University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
- University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
- Community Health Network — Indianapolis, Indiana, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Washington University School of Medicine St. Louis — St Louis, Missouri, United States (enrolling)
- Renown Regional Medical Center — Reno, Nevada, United States (enrolling)
- Rutgers University — New Brunswick, New Jersey, United States (enrolling)
- NYU Langone — New York, New York, United States (enrolling)
- Columbia University Herbert Irving Comprehensive Cancer Center — New York, New York, United States (enrolling)
- Memorial Sloan Kettering — New York, New York, United States (enrolling)
- Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
- University of Utah- Huntsman Cancer Center — Salt Lake City, Utah, United States (enrolling)
- Inova Schar Cancer Center — Fairfax, Virginia, United States (enrolling)
- NEXT Virginia — Fairfax, Virginia, United States (enrolling)
- UW Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
- St Vincents Hospital — Sydney, New South Wales, Australia (enrolling)
Full record on ClinicalTrials.gov
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