Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
Study NCT ID:
NCT06738966
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2024-12-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
Sponsor:
Shanghai Best-Link Bioscience, LLC
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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?
* 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?
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: