OncoMatch/Clinical Trials/NCT06239467
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
Is NCT06239467 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for advanced cancer.
Treatment: OKI-219 · Fulvestrant · Trastuzumab · Tucatinib · Atirmociclib · Ribociclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Breast Carcinoma
Biomarker criteria
Required: PIK3CA H1047R mutation
documented evidence of a PI3KαH1047R mutation in tumor tissue and/or blood (ie, ctDNA)
Required: KRAS wild-type
Participants with colorectal cancer must have KRAS wild-type disease.
Excluded: KRAS mutation
Participants with a known KRAS mutation.
Excluded: PTEN deleterious mutation
Participants with a known deleterious mutation in phosphatase and tensin homolog (PTEN)
Excluded: PTEN negative protein expression by IHC
negative for PTEN protein expression by IHC
Disease stage
Required: Stage III, IV
locally advanced, unresectable or metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hormonal therapy — advanced or metastatic
must have received at least 1 prior line of hormonal therapy in the advanced or metastatic setting
Must have received: CDK4/6 inhibitor — advanced or metastatic
at least 1 prior line of CDK4/6-inhibitor in the advanced or metastatic setting
Must have received: taxane
must have received prior taxane
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab, tucatinib)
must have received prior taxane, trastuzumab, pertuzumab, and tucatinib
Must have received: antibody-drug conjugate (trastuzumab deruxtecan)
must have received prior trastuzumab deruxtecan
Cannot have received: investigational product
Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, of the start of treatment
Cannot have received: anticancer therapy
Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, of the start of treatment
Lab requirements
Blood counts
Adequate organ and bone marrow function
Kidney function
Adequate organ and bone marrow function
Liver function
Adequate organ and bone marrow function
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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