A Clinical Trial Comparing the Efficacy and Safety of Different Doses of BL0175 Injection in Trea… (NCT07658183) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
120 participantsStarted 2026-07-20
Plain-language 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?
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntary participation in the trial, understanding the specific procedures of the trial, and willing to sign a written informed consent form.
. Age ≥ 18 years.
. HR positive, HER2 negative, with locally advanced or metastatic breast cancer in postmenopausal patients during or after endocrine therapy.
. The blood pregnancy test result during the screening period must be negative (if the postmenopausal state is caused by GnRH agonists).
. If the postmenopausal state is caused by GnRH agonists, the trial participants must agree to take effective contraceptive measures from the time of enrollment until at least 2 years after the last administration of the study treatment. For patients with breast cancer, the use of estrogen-based hormonal contraceptive methods (including hormone-type intrauterine devices) is not allowed, while the efficacy of progestin-based hormonal contraceptive methods is currently unclear. Effective contraceptive measures include: a. Complete abstinence (if it is their preferred regular lifestyle); b. Intrauterine device; c. Bilateral tubal ligation; d. The partner has undergone vasectomy and confirmed no sperm; e. Dual barrier method (male condom combined with cervical cap, vaginal diaphragm, or contraceptive sponge in combination with spermicidal agent).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing different doses of a drug called BL0175 injection, which sounds like it's still being evaluated for the right dosing — what does it mean for my safety that Phase 2 is still figuring out which dose works best, and how does that uncertainty compare to my standard treatment options?
2The trial is specifically for postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer — based on my exact diagnosis and test results, do I actually fit the profile this study is designed for?
3The trial isn't recruiting yet — do you know when it might open, and given how my cancer may need treatment soon, is it realistic for me to wait to see if I could potentially join, or should we be pursuing another plan now?
4The main thing this trial is measuring is called 'Objective Response Rate' — can you explain what that means in plain terms, and how it helps us understand whether BL0175 might actually be shrinking tumors compared to treatments I could get today?
5Are there established treatments for HR-positive, HER2-negative metastatic breast cancer — like CDK4/6 inhibitors or other hormone therapies — that I should consider before or instead of exploring an early-phase trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate Evaluated by Blinded Independent Central Review
. The Eastern Cooperative Oncology Group (ECOG) status score at screening must be ≤ 1.
. Life expectancy ≥ 12 weeks.
Exclusion criteria
. Participants with symptomatic central nervous system (CNS) metastases or cancerous meningitis;
. Have a history of other primary malignant tumors (except for participants who have been cured of skin basal cell carcinoma, skin squamous cell carcinoma, or cervical carcinoma in situ, and participants with other primary tumors that have no evidence of disease for 2 years or more and do not require treatment).
. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.
. Participants who have a history of allogeneic transplantation (including but not limited to allogeneic organ, bone marrow, or stem cell transplantation).
. A history of allergic to fulvestrant, or prone to allergic reactions (such as prone to angioedema, urticaria, asthma, rash, etc.).
. Severe cardiovascular or cerebrovascular diseases, including: Heart failure classified as New York Heart Association (NYHA) functional class III-IV (assessment only for patients with a history of heart disease), or left ventricular ejection fraction (LVEF) \<50% (if LVEF data are available); Uncontrolled ventricular arrhythmias: baseline QT interval corrected by Fridericia method (QTcF) \> 480 ms, or congenital long QT syndrome; Myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism, or other clinically significant thromboembolic events occurring within 6 months prior to the first administration of the investigational drug, or coronary artery bypass graft surgery performed within 6 months prior to the first administration of the investigational drug; Clinically symptomatic bradycardia as assessed by the investigator; Other clinically significant cardiovascular diseases that, in the opinion of the investigator, make the patient unsuitable for participation in the trial.
. Human immunodeficiency virus (HIV) infection or positive HIV antibody test at screening.
. Active hepatitis B (HBV DNA ≥2000 IU/mL) or active hepatitis C (HCV RNA ≥200 IU/mL). Additionally, eligible participants with hepatitis B or C must agree to receive antiviral treatment according to established guidelines; otherwise, they will not be enrolled.