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First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06239467•OnKure, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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.
+8 more criteria

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
+5 more criteria

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

Key Dates

Start Date

February 26, 2024

Primary Completion Date

June 1, 2026

Completion Date

August 1, 2027

Last Updated

September 9, 2025

Enrollment

200

ESTIMATED participants

Conditions

Advanced CancerBreast CancerAdvanced Solid TumorsPI3K Gene Mutation

Interventions

OKI-219

DRUG

Fulvestrant

DRUG

Trastuzumab

DRUG

Tucatinib

DRUG

Atirmociclib

DRUG

Ribociclib

DRUG

Contacts

OnKure, Inc.

CONTACT

720-307-2892 info@onkure.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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