First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Running, not enrolling · Phase 1
Conditions studied: Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation
In brief
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.
Key facts
- Study ID
- NCT06239467
- Run by
- OnKure, Inc.
- People needed
- 200
- Starts
- 2024-02-26
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- 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
Full record on ClinicalTrials.gov
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