First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
NCT ID: NCT06239467
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2024-02-26
2027-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a: Part A Dose Escalation
OKI-219 Monotherapy Dose Escalation in participants with advanced solid tumors with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Phase 1b: Part B Dose Escalation
OKI-219 + Fulvestrant Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Fulvestrant
Intramuscular injection
Phase 1b: Part B Dose Optimization
OKI-219 + Fulvestrant Dose Optimization in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Fulvestrant
Intramuscular injection
Phase 1b: Part C Dose Escalation
OKI-219 + Tucatinib + Trastuzumab Dose Escalation in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Trastuzumab
Intravenous (IV)
Tucatinib
Oral twice daily
Phase 1b: Part C Dose Expansion
OKI-219 + Tucatinib + Trastuzumab Dose Expansion in participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Trastuzumab
Intravenous (IV)
Tucatinib
Oral twice daily
Phase 1b: Part D Dose Escalation
OKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Fulvestrant
Intramuscular injection
Atirmociclib
Oral twice daily
Phase 1b: Part D Dose Expansion
OKI-219 + Fulvestrant + Atirmociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Fulvestrant
Intramuscular injection
Atirmociclib
Oral twice daily
Phase 1b: Part E Dose Escalation
OKI-219 + Fulvestrant + Ribociclib Dose Escalation in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Fulvestrant
Intramuscular injection
Ribociclib
Oral once daily continuous for 21-days followed by 7 days off
Phase 1b: Part E Dose Expansion
OKI-219 + Fulvestrant + Ribociclib Dose Expansion in participants with HR+/HER2- locally advanced, unresectable or metastatic breast cancer with the PI3KαH1047R mutation
OKI-219
Oral twice daily
Fulvestrant
Intramuscular injection
Ribociclib
Oral once daily continuous for 21-days followed by 7 days off
Interventions
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OKI-219
Oral twice daily
Fulvestrant
Intramuscular injection
Trastuzumab
Intravenous (IV)
Tucatinib
Oral twice daily
Atirmociclib
Oral twice daily
Ribociclib
Oral once daily continuous for 21-days followed by 7 days off
Eligibility Criteria
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Inclusion Criteria
* 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.
* Participants with colorectal cancer must have KRAS wild-type disease.
Part B
* Participants with locally advanced, unresectable or metastatic HR+/HER2- breast cancer must have received at least 1 prior line of hormonal therapy in the advanced or metastatic setting and at least 1 prior CDK4/6-inhibitor.
* Participants with HER2-low breast cancer should have received prior trastuzumab deruxtecan
Part C ● Participants with HR±/HER2+ locally advanced, unresectable or metastatic breast cancer must have received prior taxane, trastuzumab, and pertuzumab unless unavailable in the region or contraindicated. Prior trastuzumab deruxtecan is allowed but not required.
Part D
● Participants must have HR+/HER2- locally advanced, unresectable or metastatic breast cancer
Part E ● Participants must have HR+/HER2- locally advanced, unresectable or metastatic breast cancer.
Exclusion Criteria
* 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
Part C:
* Grade 2 or higher diarrhea at study entry.
* History of chronic liver disease.
Part E:
● History of interstitial lung disease.
18 Years
ALL
No
Sponsors
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OnKure, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OKI-219-101
Identifier Type: -
Identifier Source: org_study_id
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