Actively Recruiting
A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
Led by Shanghai Best-Link Bioscience, LLC · Updated on 2026-01-13
9
Participants Needed
2
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and able to understand study requirements with signed consent
- Age 18 years or older
- Postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer with progression after endocrine therapy, or locally advanced or metastatic ovarian or endometrial cancer after prior standard therapy
- At least one measurable or evaluable lesion assessable by CT, MRI, or X-ray
- ECOG performance status of 0 or 1 at screening
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Symptomatic central nervous system metastases or carcinomatous meningitis (treated stable CNS metastases allowed under conditions)
- History of another primary cancer within 3 years (except certain skin or cervical cancers)
- Uncontrollable pericardial, pleural effusion, or ascites
- History of organ, bone marrow or stem cell transplantation
- Allergy or adverse response to fulvestrant or prone to allergic reactions like angioedema or asthma
- Significant cardiac diseases including NYHA class III-IV, LVEF <50%, unstable arrhythmias, recent major cardiac events, or symptomatic bradycardia
- Known HIV infection or positive HIV antibody test
- Active hepatitis B or C infection not under antiviral treatment
- Active infections needing IV antibiotics within 1 week prior to enrollment
- Moderate to severe liver impairment (Child-Pugh B or C)
- Insufficient baseline organ function as defined by lab criteria
- Recent treatment with chemotherapy, immunotherapy, radiotherapy, monoclonal antibodies, or investigational drugs within defined washout periods
- Bleeding disorders or long-term anticoagulant therapy (excluding some low dose treatments)
- Severe vascular embolism events requiring intervention
- Active autoimmune diseases needing systemic treatment (some hormone therapies allowed)
- Systemic corticosteroids within 4 weeks prior to study drug (low doses excluded)
- Major surgery within 4 weeks before enrollment or planned during study
- Unresolved toxicity from prior treatments greater than grade 1 CTCAE
- Any other investigator-determined disqualifying condition
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
2
Jinan Central Hospital
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
G
Guat Hoon Ong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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