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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Ogólny stan zdrowia pacjenta musi być dobry (skala 0-1)
- •Potwierdzona mutacja genu PIK3CA we krwi lub w guzie
- •Dostępna próbka tkanki guza lub zgoda na biopsję przed leczeniem
- •Guz, który nie poddaje się standardowemu leczeniu lub pacjent go nie toleruje
- •Potwierdzony rozległy lub przerzutujący nowotwór litego
- •Dla raka piersi: hormonowrażliwy (HR+) i bez nadekspresji HER2
- •Pacjent otrzymał co najmniej jeden inhibitor CDK4/6 wcześniej
- •Pacjent otrzymał co najmniej jedną terapię hormonalną wcześniej
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 22, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (37)
The University of Arizona Cancer Center
Tucson, United States
University of California-San Diego
San Diego, United States
HealthONE
Denver, United States
Yale University
New Haven, United States
Florida Cancer Specialists
Orlando, United States
Boca Raton Clinical Research (BRCR) Global
Plantation, United States
University of Chicago Medical Center
Chicago, United States
Community Health Network
Indianapolis, United States
Massachusetts General Hospital
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
University of Michigan
Ann Arbor, United States
Washington University School of Medicine St. Louis
St Louis, United States
Renown Regional Medical Center
Reno, United States
Rutgers University
New Brunswick, United States
NYU Langone
New York, United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, United States
Memorial Sloan Kettering
New York, United States
Tennessee Oncology
Nashville, United States
University of Texas Southwestern Medical Center
Dallas, United States
The University of Texas M.D. Anderson Cancer Center
Houston, United States
University of Utah- Huntsman Cancer Center
Salt Lake City, United States
Inova Schar Cancer Center
Fairfax, United States
NEXT Virginia
Fairfax, United States
UW Carbone Cancer Center
Madison, United States
St Vincents Hospital
Sydney, Australia
Peter MacCallum Cancer Center
Melbourne, Australia
The Alfred Hospital
Melbourne, Australia
Centre Léon Bérard
Lyon, France
Institute Bergonié
Bordeaux, France
Gustave Roussy
Villejuif, France
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Vall d'Hebron Instituto de Oncologia
Barcelona, Spain
START Barcelona
Barcelona, Spain
Instituto Valenciano de Oncologia
Valencia, Spain
Institut Catala D'Oncologia - Badalona (ICO Badalona)
Barcelona, Spain
START Madrid - Hospital Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Trial contact
Relay Therapeutics Inc
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.