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NCT06239467 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
A Phase 1 study of Breast Cancer and Advanced Solid Tumors, sponsored by OnKure.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06239467: Recruiting Phase 1 study of Breast Cancer and Advanced Solid Tumors, sponsored by OnKure.
NCT06239467 is a Phase 1 study of Breast Cancer and Advanced Solid Tumors that is actively recruiting participants, run by OnKure. The registered enrollment target is 200 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06239467, a Phase 1 study of Breast Cancer and Advanced Solid Tumors, is actively recruiting participants, sponsored by OnKure.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Frequency of participants experiencing dose-limiting toxicities during the first 28-day cycle
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Fulvestrant
- DRUG Tucatinib
- DRUG Atirmociclib
- DRUG OKI-219
Study Locations (20)
Other
- Institut Jules Bordet - Anderlecht
- UZ Leuven - Campus Gasthuisberg - Leuven
- GZA Hopsitals Campus Sint-Augustinus - Wilrijk
- Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL) - Dijon
- Centre Oscar Lambret - Lille
- Centre Leon Berard - Lyon
- Centre Antoine Lacassagne - Nice
California
- California Cancer Associates for Research and Excellence - Encinitas
- University of California San Diego UCSD - La Jolla
- UCLA Jonsson Comprehensive Cancer Center - Los Angeles
- Hoag - Huntington Beach - Newport Beach
Colorado
- Regents of the University of Colorado - Aurora
- Sarah Cannon Research Institute at HealthONE - Denver
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Karmanos Cancer Insitute - Detroit
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
New York
- Stony Brook University - Stony Brook
Tennessee
- SCRI Oncology Partners - Nashville - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-02-26 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 1 |
What NCT06239467 shows while recruiting
NCT06239467 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT06239467 names 20 study sites across 10 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06239467 about?
NCT06239467 is a clinical study titled "First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer". 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 escala...
What is the current status of trial NCT06239467?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2024-02-26. Estimated completion is 2027-08-01.
What conditions does trial NCT06239467 study?
This clinical trial studies the following conditions: Breast Cancer, Advanced Solid Tumors, Advanced Cancer, PI3K Gene Mutation.
What interventions are being tested in trial NCT06239467?
The interventions under investigation include: Trastuzumab (DRUG), Fulvestrant (DRUG), Tucatinib (DRUG), Atirmociclib (DRUG), OKI-219 (DRUG).
Who is sponsoring clinical trial NCT06239467?
This trial is sponsored by OnKure, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06239467 being conducted?
This trial has 20 study locations across California, Colorado, Massachusetts, Michigan, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06239467's enrollment target sits among peer trials
200 362nd of 1224 higher than 841 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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