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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-18

No results posted yet for this study

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?

Conditions

  • Breast Cancer (Locally Advanced or Metastatic)

Interventions

DRUG

BL0175

BL0175 is a nano-medicine for cancer therapy. "Nano-medicine" means the tiny size of this study drug allows it to enter and concentrate into the tumor tissue. This is a new way of delivering an active drug (an estrogen receptor down regulator) for the treatment of tumor directly into tumor tissue.

Sponsors & Collaborators

  • Shanghai Best-Link Bioscience, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2027-10-31
Completion
2028-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658183 on ClinicalTrials.gov