New drug targets Hard-to-Treat cancers with PI3K mutation

NCT ID NCT06239467

Ongoing Disease control Sponsor: OnKure, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called OKI-219 in people with advanced solid tumors or breast cancer that have a specific PI3K gene mutation. The drug is designed to block the mutant protein and slow cancer growth. Up to 200 participants will receive OKI-219 alone or combined with other cancer drugs to find the safest dose and see if it works.

What this could mean

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

Active substance: OKI-219 (a targeted drug that blocks a specific mutant protein called PI3KαH1047R)
What this could lead to: If successful, this could lead to a new treatment option for people with advanced cancers that have a specific PI3K mutation, especially breast cancer.
What could go wrong: This is an early Phase 1 trial, so the drug may not be safe or effective. Side effects could be serious, and the benefit is uncertain.

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 cancer colorectal cancer HER2 positive breast carcinoma hormone receptor-positive breast cancer neoplasm

As listed by the trial registrant

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

ADVANCED CANCER ADVANCED SOLID TUMORS BREAST CANCER PI3K GENE MUTATION

Contacts and locations

Locations

Asan Medical Center

Seoul, 05505, South Korea
California Cancer Associates for Research and Excellence

Encinitas, California, 92024, United States
Centre Antoine Lacassagne

Nice, 06189, France
Centre Leon Berard

Lyon, 69008, France
Centre Oscar Lambret

Lille, 59020, France
Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL)

Dijon, 21079, France
Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States
Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States
GZA Hopsitals Campus Sint-Augustinus

Wilrijk, 2610, Belgium
Gachon University Gil Medical Center

Incheon, 21565, South Korea
Hoag - Huntington Beach

Newport Beach, California, 92663, United States
Hopital Lyon Sud

Pierre-Bénite, 69310, France
Hospital Beata Maria Ana

Madrid, 28007, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Institut Gustave Roussy

Villejuif, 94805, France
Institut Jules Bordet

Anderlecht, 1070, Belgium
Istituto Clinico Humanitas

Rozzano, 20089, Italy
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
NEXT Oncology Phase I Unit / IOB- Hospital Quironsalud Barcelona

Barcelona, 08023, Spain
NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States
Ospedale San Gerardo-ASST Monza

Monza, 20900, Italy
Ospedale San Raffaele

Milan, 20132, Italy
Regents of the University of Colorado

Aurora, Colorado, 80045, United States
SCRI Oncology Partners - Nashville

Nashville, Tennessee, 37203, United States
START - Madrid

Madrid, 28050, Spain
Samsung Medical Center

Seoul, 06351, South Korea
Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States
Seoul National University Hospital

Seoul, 03080, South Korea
Severance Hospital

Seoul, 03722, South Korea
Stony Brook University

Stony Brook, New York, 11794, United States
UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90024, United States
UZ Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium
University of California San Diego UCSD

La Jolla, California, 92093, United States

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