Actively Recruiting
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Led by OnKure, Inc. · Updated on 2025-09-09
200
Participants Needed
34
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with advanced solid tumors with documented evidence of a PI3KB1H1047R mutation in tumor tissue and/or blood
- Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 to 1
- Life expectancy greater than 12 weeks for Part A and greater than 6 months for Parts B, C, D, and E
- Adequate organ and bone marrow function
- Availability of adequate archival tumor tissue sample or Sponsor approval if no tumor sample is available
- At least one measurable lesion based on RECIST version 1.1
- For Part A, participants with HR+/HER2- breast cancer must have had at least one prior line of hormonal therapy and one prior line of CDK4/6-inhibitor
- For Part A, participants with HER2+ breast cancer must have received prior taxane, trastuzumab, pertuzumab, and tucatinib; prior trastuzumab deruxtecan is allowed
- For Part A, participants with HER2-low breast cancer must have received prior trastuzumab deruxtecan
- For Part A, participants with colorectal cancer must have KRAS wild-type disease
- For Part B, participants with HR+/HER2- breast cancer must have received at least one prior hormonal therapy and one prior CDK4/6-inhibitor
- For Part B, participants with HER2-low breast cancer should have received prior trastuzumab deruxtecan
- For Part C, participants with HR+/HER2+ breast cancer must have received prior taxane, trastuzumab, and pertuzumab unless unavailable or contraindicated; prior trastuzumab deruxtecan allowed
- For Parts D and E, participants must have HR+/HER2- breast cancer
You will not qualify if you...
- Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives before starting treatment
- Known KRAS mutation
- Known deleterious mutation in PTEN or negative PTEN protein expression by immunohistochemistry
- Major surgery or wide-field radiation within 28 days or limited-field palliative radiation within 7 days before first study drug dose
- Known active central nervous system metastasis, including leptomeningeal disease
- Uncontrolled Type 1 or Type 2 diabetes with HbA1C 2 8%
- Concomitant active malignancy or previous malignancy within 2 years before enrollment
- Impaired cardiovascular function or significant cardiovascular disease
- History of symptomatic drug-induced pneumonitis
- Active HIV, Hepatitis B, or Hepatitis C viral infections
- For Part C, grade 2 or higher diarrhea at study entry and history of chronic liver disease
- For Part E, history of interstitial lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
California Cancer Associates for Research and Excellence
Encinitas, California, United States, 92024
Actively Recruiting
2
University of California San Diego UCSD
La Jolla, California, United States, 92093
Actively Recruiting
3
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90024
Actively Recruiting
4
Hoag - Huntington Beach
Newport Beach, California, United States, 92663
Actively Recruiting
5
Regents of the University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Karmanos Cancer Insitute
Detroit, Michigan, United States, 48201
Withdrawn
9
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Actively Recruiting
10
Stony Brook University
Stony Brook, New York, United States, 11794
Actively Recruiting
11
SCRI Oncology Partners - Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
13
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
14
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
15
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
16
GZA Hopsitals Campus Sint-Augustinus
Wilrijk, Belgium, 2610
Actively Recruiting
17
Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL)
Dijon, France, 21079
Actively Recruiting
18
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
19
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
20
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
21
Hopital Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
22
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
23
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
24
Ospedale San Gerardo-ASST Monza
Monza, Italy, 20900
Actively Recruiting
25
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
26
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
27
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
28
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
29
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
30
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
31
NEXT Oncology Phase I Unit / IOB- Hospital Quironsalud Barcelona
Barcelona, Spain, 08023
Actively Recruiting
32
Hospital Beata Maria Ana
Madrid, Spain, 28007
Actively Recruiting
33
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
34
START - Madrid
Madrid, Spain, 28050
Actively Recruiting
Research Team
O
OnKure, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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