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Study identifier: NCT06239467 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Active Not Recruiting

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

Condition: Advanced Cancer · Breast Cancer · Advanced Solid Tumors  ·  Sponsor: OnKure, Inc.

PhasePhase 1
Planned participants200
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (33)

California Cancer Associates for Research and ExcellenceEncinitas, California, United States
University of California San Diego UCSDLa Jolla, California, United States
UCLA Jonsson Comprehensive Cancer CenterLos Angeles, California, United States
Hoag - Huntington BeachNewport Beach, California, United States
Regents of the University of ColoradoAurora, Colorado, United States
Sarah Cannon Research Institute at HealthONEDenver, Colorado, United States
Massachusetts General HospitalBoston, Massachusetts, United States
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada, United States
Stony Brook UniversityStony Brook, New York, United States
SCRI Oncology Partners - NashvilleNashville, Tennessee, United States
NEXT Oncology VirginiaFairfax, Virginia, United States
Fred Hutchinson Cancer CenterSeattle, Washington, United States

+ 21 more locations — full list on the registry record.

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