drugset / Trial / NCT06570031
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.
Timeline
- Start
- 2021-11-09
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | — | — |
| Subject | BMS-986310 | Small molecule | — | — |
| Subject | Palbociclib | Small molecule | — | — |
| Background | Letrozole | Other / unclassified | — | — |