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 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: BL0175-201
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Which dose level of BL0175 demonstrates the optimal ORR?
2. 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)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate Evaluated by Blinded Independent Central Review

  12 months

Secondary Outcomes (11)

• Progression Free Survival Evaluated by BICR

  12 months

• Clinical Benefit Rate Evaluated by BICR

  12 months

• Disease Control Rate Evaluated by BICR

  12 months

• Duration of Response Evaluated by BICR

  12 months

• Objective Response Rate Evaluated by the Investigator

  12 months

Study Arms (2)

BL0175 250mg

EXPERIMENTAL

Drug: BL0175

BL0175 500mg

EXPERIMENTAL

Drug: BL0175

Interventions

BL0175 DRUG

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.

BL0175 250mg; BL0175 500mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• At least one measurable lesion exists.
• The Eastern Cooperative Oncology Group (ECOG) status score at screening must be ≤ 1.
• Life expectancy ≥ 12 weeks.

You may not qualify if:

• 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.
• Active infection requiring intravenous antibiotic therapy within 1 week prior to the first administration of the investigational drug.
• Moderate or severe hepatic impairment, defined as meeting Child-Pugh classification criteria B or C.
• Insufficient organ function reserve at baseline, as defined by any of the following criteria (no blood products \[including platelets or red blood cells\] or colony-stimulating factors \[including granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin\] administered within 7 days prior to testing): Absolute neutrophil count (ANC) \<1.5×10⁹/L; Total bilirubin \>1.5×ULN; ALT or AST \>3×ULN if no liver metastasis is present; ALT or AST \>5×ULN if liver metastasis is present; Hemoglobin (Hb) \<90 g/L; Platelet count (PLT) \<100×10⁹/L; International Normalized Ratio (INR) \>1.5 (for patients on anticoagulant therapy, values within therapeutic range are acceptable); Creatinine clearance \<30 mL/min.
• Receipt of anti-tumor drugs or investigational agents within the following time intervals prior to the first administration of the investigational drug: Anti-tumor endocrine therapy, targeted small-molecule therapy, or radiotherapy (except palliative radiotherapy or radiotherapy not involving the planned target lesion) ≤14 days or 5 half-lives (whichever is shorter); Chemotherapy ≤28 days or 5 half-lives (whichever is shorter); Immunotherapy or cell therapy (e.g., chimeric antigen receptor T-cell therapy) ≤28 days; other forms of cell therapy must be discussed with the investigator to determine eligibility; Monoclonal antibodies used for anti-tumor treatment ≤28 days; Traditional Chinese medicine with a clearly defined anti-tumor indication ≤14 days; Immunosuppressive therapy for any reason ≤7 days; All other investigational drugs or devices ≤28 days or 5 half-lives (whichever is shorter).
• Bleeding disorders (e.g., disseminated intravascular coagulation, deficiency of coagulation factors), or requiring long-term anticoagulant therapy (excluding antiplatelet therapy and low-dose warfarin or low-molecular-weight heparin).
• Severe vascular embolic events requiring medical or surgical intervention.
• Active autoimmune diseases requiring systemic treatment (including use of immunomodulatory agents, corticosteroids, or immunosuppressive drugs).

Sponsors & Collaborators

• Shanghai Best-Link Bioscience, LLC: lead

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lun Zhuo Fang

CONTACT

86+18357916536; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 18, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06