OKI-219 + fulvestrant + ribociclib

This is a **combination investigational cancer therapy** comprising three agents: - **OKI-219**: a first-in-class, small molecule inhibitor selectively targeting the PI3KαH1047R mutation (a hotspot oncogenic mutation in PIK3CA), under development for advanced solid tumors and breast cancer. - **Fulvestrant**: an estrogen receptor antagonist, approved for hormone receptor-positive (HR+) breast cancer, functioning as a selective estrogen receptor degrader (SERD) that induces degradation of the estrogen receptor. - **Ribociclib**: a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved for HR+ HER2- advanced breast cancer, acting by blocking cell cycle progression. This particular combination is under investigation in the **PIKture-01 (OKI-219-101) Phase 1 trial** in patients with HR+/HER2- locally advanced, unresectable, or metastatic breast cancer harboring the PI3KαH1047R mutation, especially after prior endocrine and CDK4/6 inhibitor therapy[1][3][4].