drugset / Trial / NCT07658183
A Clinical Trial Comparing the Efficacy and Safety of Different Doses of BL0175 Injection in Treating Postmenopausal Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to compare the objective response rates (ORR) of different doses of BL0175 in patients with postmenopausal hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. The main questions it aims to answer are: 1. Which dose level of BL0175 demonstrates the optimal ORR? 2. What is the recommended phase 3 dose (RP3D) based on efficacy and safety data across the tested dose levels?
Timeline
- Start
- 2026-07-20
- Primary completion
- 2027-10-31
- Completion
- 2028-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BL0175 | Other / unclassified | 250 mg | — |
| Subject | BL0175 | Other / unclassified | 500 mg | — |