RecruitingPhase 1NCT06239467

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and as Part of Combination Therapy in Participants With Advanced Breast Cancer

Sponsor

OnKure, Inc.

Enrollment

200 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Advanced Cancer Advanced Solid Tumors PI3K Gene Mutation

Summary

OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs. Phase 1a (Part A) will investigate escalating doses of OKI-219 monotherapy, and Phase 1b will investigate OKI-219 (at a tolerated dose determined in Part A) in combination with fulvestrant (Part B), trastuzumab and tucatinib (Part C), atirmociclib (Part D), and ribociclib and fulvestrant (Part E). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called OKI-219 in people with advanced solid tumors or advanced breast cancer that carries a specific genetic mutation called PI3KαH1047R. This is a first-in-human trial, meaning it is the first time this drug is being tested in people — the primary focus is on safety and finding the right dose. **You may be eligible if...** - You have advanced solid tumors or advanced breast cancer - Your tumor has a confirmed PI3KαH1047R mutation (found in tumor tissue or blood test) - Your general performance status is good (ECOG 0–1) - Your organs and bone marrow are functioning adequately - You have adequate archived tumor tissue available - Your life expectancy is more than 12 weeks (or more than 6 months for expansion parts of the study) **You may NOT be eligible if...** - Your tumor does not have the PI3KαH1047R mutation - Your performance status or organ function does not meet required levels - You have conditions that would make it unsafe to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOKI-219

Oral twice daily

DRUGFulvestrant

Intramuscular injection

DRUGTrastuzumab

Intravenous (IV)

DRUGTucatinib

Oral twice daily

DRUGAtirmociclib

Oral twice daily

DRUGRibociclib

Oral once daily continuous for 21-days followed by 7 days off

Locations(34)

California Cancer Associates for Research and Excellence

Encinitas, California, United States

University of California San Diego UCSD

La Jolla, California, United States

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Hoag - Huntington Beach

Newport Beach, California, United States

Regents of the University of Colorado

Aurora, Colorado, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Insitute

Detroit, Michigan, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Stony Brook University

Stony Brook, New York, United States

SCRI Oncology Partners - Nashville

Nashville, Tennessee, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Institut Jules Bordet

Anderlecht, Belgium

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

GZA Hopsitals Campus Sint-Augustinus

Wilrijk, Belgium

Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL)

Dijon, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Centre Antoine Lacassagne

Nice, France

Hopital Lyon Sud

Pierre-Bénite, France

Institut Gustave Roussy

Villejuif, France

Ospedale San Raffaele

Milan, Italy

Ospedale San Gerardo-ASST Monza

Monza, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

NEXT Oncology Phase I Unit / IOB- Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital Beata Maria Ana

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

START - Madrid

Madrid, Spain

View Full Details on ClinicalTrials.gov

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