drugset / Trial / NCT05293964
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
Phase 1
Active not recruiting
214 enrolled
Jiangsu Simcere Pharmaceutical Co., Ltd.
Nanjing Zaiming Pharmaceutical Co., Ltd. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen receptor (ER) -positive, human epidermal growth factor receptor (HER-2) -negative locally advanced or metastatic breast cancer.
Timeline
- Start
- 2022-05-18
- Primary completion
- 2024-12-31
- Completion
- 2025-09-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | — | — |
| Subject | Palbociclib | Small molecule | — | — |
| Subject | SIM0270 | Unknown | — | Oral |