New drug targets Hard-to-Treat cancers with PIK3CA mutation

NCT ID NCT05216432

Recruiting now Disease control Sponsor: Relay Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage study is testing a new drug called RLY-2608, which is designed to block a specific mutant protein (PIK3CA) that helps some cancers grow. The trial includes people with advanced solid tumors or breast cancer that has not responded to other treatments. Participants will receive RLY-2608 alone or combined with other cancer drugs to find the safest dose and see if it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: RLY-2608 (a targeted drug that blocks a specific mutant protein in cancer cells)
What this could lead to: If successful, this could lead to a new treatment option for people with advanced solid tumors that have a specific genetic mutation (PIK3CA), potentially slowing cancer growth.
What could go wrong: This is an early Phase 1 trial, so the drug may not work as hoped or could cause serious side effects. It is also only for people with a specific mutation, so it won't apply to most cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm Her2-receptor negative breast cancer hormone receptor-positive breast cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED BREAST CANCER BREAST CANCER HER2-NEGATIVE BREAST CANCER METASTATIC BREAST CANCER PIK3CA MUTATION SOLID TUMOR, ADULT UNRESECTABLE SOLID TUMOR

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Boca Raton Clinical Research (BRCR) Global
WITHDRAWN

Plantation, Florida, 33322, United States
Centre Léon Bérard
RECRUITING

Lyon, Auvergne-Rhône-Alpes, 69008, France
Columbia University Herbert Irving Comprehensive Cancer Center
RECRUITING

New York, New York, 10032, United States
Community Health Network
RECRUITING

Indianapolis, Indiana, 46250, United States
Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Florida Cancer Specialists
RECRUITING

Orlando, Florida, 32827, United States
Gustave Roussy
RECRUITING

Villejuif, 94805, France
HealthONE
RECRUITING

Denver, Colorado, 80218, United States
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Inova Schar Cancer Center
RECRUITING

Fairfax, Virginia, 22031, United States
Institut Catala D'Oncologia - Badalona (ICO Badalona)
RECRUITING

Barcelona, 08916, Spain
Institute Bergonié
RECRUITING

Bordeaux, 33076, France
Instituto Valenciano de Oncologia
RECRUITING

Valencia, Valencia, 46009, Spain
Istituto Europeo di Oncologia IRCCS
RECRUITING

Milan, 20141, Italy
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering
RECRUITING

New York, New York, 10065, United States
NEXT Virginia
RECRUITING

Fairfax, Virginia, 22301, United States
NYU Langone
RECRUITING

New York, New York, 10016, United States
Peter MacCallum Cancer Center
RECRUITING

Melbourne, Victoria, 3000, Australia
Renown Regional Medical Center
RECRUITING

Reno, Nevada, 89502, United States
Rutgers University
RECRUITING

New Brunswick, New Jersey, 08901, United States
START Barcelona
RECRUITING

Barcelona, Catalonia, 08023, Spain
START Madrid - Hospital Fundacion Jimenez Diaz
RECRUITING

Madrid, 28040, Spain
St Vincents Hospital
RECRUITING

Sydney, New South Wales, 2019, Australia
Tennessee Oncology
RECRUITING

Nashville, Tennessee, 37203, United States
The Alfred Hospital
RECRUITING

Melbourne, Victoria, 3004, Australia
The University of Arizona Cancer Center
RECRUITING

Tucson, Arizona, 85724, United States
The University of Texas M.D. Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
UW Carbone Cancer Center
RECRUITING

Madison, Wisconsin, 53792, United States
University of California-San Diego
RECRUITING

San Diego, California, 90293, United States
University of Chicago Medical Center
RECRUITING

Chicago, Illinois, 60637, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Texas Southwestern Medical Center
RECRUITING

Dallas, Texas, 75235, United States
University of Utah- Huntsman Cancer Center
RECRUITING

Salt Lake City, Utah, 84112, United States
Vall d'Hebron Instituto de Oncologia
RECRUITING

Barcelona, Barcelona, 08035, Spain
Washington University School of Medicine St. Louis
RECRUITING

St Louis, Missouri, 63110, United States
Yale University
RECRUITING

New Haven, Connecticut, 06510, United States

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