drugset / Trial / NCT05504213
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus fulvestrant in patients with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast cancer (ABC) harboring PIK3CA mutations.
Timeline
- Start
- 2022-01-12
- Primary completion
- 2023-07-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | HS-10352 | Small molecule | — | Oral |