First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Public ClinicalTrials.gov record NCT06239467. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and as Part of Combination Therapy in Participants With Advanced Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06239467
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 200 participants
Conditions and interventions
Interventions
- OKI-219 Drug
- Fulvestrant Drug
- Trastuzumab Drug
- Tucatinib Drug
- Atirmociclib Drug
- Ribociclib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 25, 2024
- Primary completion
- Dec 30, 2026
- Completion
- Jul 31, 2027
- Last update posted
- Jul 5, 2026
2024 – 2027
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Cancer Associates for Research and Excellence | Encinitas | California | 92024 | — |
| University of California San Diego UCSD | La Jolla | California | 92093 | — |
| UCLA Jonsson Comprehensive Cancer Center | Los Angeles | California | 90024 | — |
| Hoag - Huntington Beach | Newport Beach | California | 92663 | — |
| Regents of the University of Colorado | Aurora | Colorado | 80045 | — |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Stony Brook University | Stony Brook | New York | 11794 | — |
| SCRI Oncology Partners - Nashville | Nashville | Tennessee | 37203 | — |
| NEXT Oncology Virginia | Fairfax | Virginia | 22031 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06239467, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 5, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06239467 live on ClinicalTrials.gov.