NCT06738966

A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer

An International, Multi-Center, Open-label Phase I Study to Evaluate the Tolerance, Pharmacokinetics, and Anti-Tumor Effects of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shanghai Best-Link Bioscience, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the investigational drug BL0175 works to treat adult postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor (HER2)-negative locally advanced or metastatic breast cancer, ovarian cancer and endometrial cancer. It will also learn about the safety of BL0175. The main questions it aims to answer are: * Does the investigational drug BL0175 is safe for participants after dosed -multiple times? * Which is the highest safety dose of BL0175 after multiple dose? * What medical problems do participants have when using BL0175? * Does the investigational drug BL0175 works for participants after dosed -multiple times?

Conditions

• Breast Cancer
• Ovarian Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-02-20
• Completion: 2027-12-26
• First posted: 2024-12-18
• Last updated: 2026-01-13

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study