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

NCT ID NCT06239467

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participants with advanced solid tumors with documented evidence of a PI3KαH1047R mutation in tumor tissue and/or blood (ie, ctDNA). * Eastern Cooperative Oncology Group (ECOG) Performance status score of to 1. * Life expectancy \> 12 weeks for Part A and \> 6 months for Parts B, C, D, and E in the opinion of the Investigator. * Adequate organ and bone marrow function * Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available. * At least 1 measurable lesion based on RECIST version 1.1. Additional Cohort-specific key inclusion criteria: Part A * Participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer, must have received at least 1 prior line of hormonal therapy and at least 1 prior line of CDK4/6-inhibitor in the advanced or metastatic setting. * Participants with HER2+ locally advanced, unresectable or metastatic breast cancer, must have received prior taxane, trastuzumab, pertuzumab, and tucatinib. Prior trastuzumab deruxtecan is allowed but not required. * Participants with HER2-low breast cancer must have received prior trastuzumab deruxtecan. * Participants with colorectal cancer must have KRAS wild-type disease. Part B * Participants with locally advanced, unresectable or metastatic HR+/HER2- breast cancer must have received at least 1 prior line of hormonal therapy in the advanced or metastatic setting and at least 1 prior CDK4/6-inhibitor. * Participants with HER2-low breast cancer should have received prior trastuzumab deruxtecan Part C ● Participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer must have received prior taxane, trastuzumab, and pertuzumab unless unavailable in the region or contraindicated. Prior trastuzumab deruxtecan is allowed but not required. Part D ● Participants must have HR+/HER2- locally advanced, unresectable or metastatic breast cancer Part E ● Participants must have HR+/HER2- locally advanced, unresectable or metastatic breast cancer. Key Exclusion Criteria: * Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, of the start of treatment * Participants with a known KRAS mutation. * Participants with a known deleterious mutation in phosphatase and tensin homolog (PTEN) or negative for PTEN protein expression by IHC. * Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of study drug. * Known active central nervous system metastasis, including leptomeningeal disease. * Uncontrolled Type 1 or Type 2 diabetes as defined by HbA1C ≥ 8%. * Concomitant active malignancy or previous malignancy within 2 years of the time of enrollment. * Impaired cardiovascular function or clinically significant cardiovascular disease, * History of symptomatic drug-induced pneumonitis. * Participants with active HIV, Hepatitis B, and Hepatitis C viral infections Additional Cohort-specific key exclusion criteria: Part C: * Grade 2 or higher diarrhea at study entry. * History of chronic liver disease. Part E: ● History of interstitial lung disease.

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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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