Condition: PIK3CA Mutation · Solid Tumor, Adult · HER2-negative Breast Cancer · Sponsor: Relay Therapeutics, Inc.
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).
This description comes directly from the study's public registry record.
Relay Therapeutics Inc · 617-322-0731 · ClinicalTrials@relaytx.com
Always discuss trial participation with your own doctor first.
| The University of Arizona Cancer Center | Tucson, Arizona, United States | Recruiting |
| University of California-San Diego | San Diego, California, United States | Recruiting |
| HealthONE | Denver, Colorado, United States | Recruiting |
| Yale University | New Haven, Connecticut, United States | Recruiting |
| Florida Cancer Specialists | Orlando, Florida, United States | Recruiting |
| Boca Raton Clinical Research (BRCR) Global | Plantation, Florida, United States | Withdrawn |
| University of Chicago Medical Center | Chicago, Illinois, United States | Recruiting |
| Community Health Network | Indianapolis, Indiana, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
| Washington University School of Medicine St. Louis | St Louis, Missouri, United States | Recruiting |
+ 25 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT05216432