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

NCT07658183

Phase 2 Not yet recruiting 120 enrolled Shanghai Best-Link Bioscience, LLC
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

EvaluationDrugModalityDoseRoute
Subject BL0175 Other / unclassified 250 mg
Subject BL0175 Other / unclassified 500 mg