First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer (NCT06239467)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: California Cancer Associates for Research and Excellence — Encinitas, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (33 Sites)
Showing the first 25 of 33 sites.
- California Cancer Associates for Research and Excellence — Encinitas, California
- University of California San Diego UCSD — La Jolla, California
- UCLA Jonsson Comprehensive Cancer Center — Los Angeles, California
- Hoag - Huntington Beach — Newport Beach, California
- Regents of the University of Colorado — Aurora, Colorado
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado
- Massachusetts General Hospital — Boston, Massachusetts
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada
- Stony Brook University — Stony Brook, New York
- SCRI Oncology Partners - Nashville — Nashville, Tennessee
- NEXT Oncology Virginia — Fairfax, Virginia
- Fred Hutchinson Cancer Center — Seattle, Washington
- 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,
- Hopital Lyon Sud — Pierre-Bénite,
- Institut Gustave Roussy — Villejuif,
- Ospedale San Raffaele — Milan,
- Ospedale San Gerardo-ASST Monza — Monza,
- Istituto Clinico Humanitas — Rozzano,
- Gachon University Gil Medical Center — Incheon,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.