Health Trials

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

ConditionsAdvanced CancerBreast CancerAdvanced Solid TumorsPI3K Gene Mutation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOnKure, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Treatment with any investigational product or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, of the start of treatment

Participants with a known KRAS mutation.

Participants with a known deleterious mutation in phosphatase and tensin homolog (PTEN) or negative for PTEN protein expression by IHC.

Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of study drug.

Trial design

Treatments tested in this trial

  • OKI-219
  • Fulvestrant
  • Trastuzumab
  • Tucatinib
  • Atirmociclib
  • Ribociclib

Treatment groups

200 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators

OnKure, Inc.

Lead sponsor

Source ClinicalTrials.gov