Tersolisib

Tersolisib (STX-478, LY4064809) is a small-molecule drug developed by Eli Lilly and. Its target is PIK3CA / PI3K-alpha (the sponsor names mutant-selective PI3Kalpha (PIK3CA)). The sponsor states: Tersolisib (STX-478/LY4064809) is a mutant-selective PI3Kalpha inhibitor studied as monotherapy and in combination with fulvestrant, with or without CDK4/6-targeted endocrine therapy, in PIK3CA-mutated advanced solid tumours and HR-positive breast cancer. ClinicalTrials.gov describes the intervention as: STX-478 is a mutant-selective PI3Kα inhibitor. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT07174336 (A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)), in HR-positive / HER2-negative breast cancer. The largest, NCT05768139, plans to enrol 880 participants with primary completion expected 2030-07. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.