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 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 stud

Trial Details

NCT ID
NCT06239467
Phase
PHASE1
Sponsor
OnKure, Inc.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • OKI-219
  • Fulvestrant
  • Trastuzumab
  • Tucatinib
  • Atirmociclib
  • Ribociclib
Locations (sample)
  • Encinitas, California, United States|33.03699,-117.29198
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Newport Beach, California, United States|33.61891,-117.92895
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • Participants with advanced solid tumors with documented evidence of a PI3KαH1047R mutation in tumor tissue and/or blood (ie, ctDNA).
  • 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

For full eligibility, visit ClinicalTrials.gov.

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