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

NCT06738966 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BL0175-102
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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?

Conditions

Breast Cancer; Ovarian Cancer; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

• Area Under the Plasma Concentration Versus Time Curve (AUC)

  0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose

• Maximum Blood Concentration of Investigational Drug

  0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose

• Trough Blood Concentration of Investigational Drug

  0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose

• Half-life of Investigational Drug

  0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose

• Progression Free Survival

  From enrollment to the date of disease progress, usually of 6 months

Study Arms (5)

BL0175 50 mg

EXPERIMENTAL

Drug: BL0175

BL0175 100 mg

EXPERIMENTAL

Drug: BL0175

BL0175 200 mg

EXPERIMENTAL

Drug: BL0175

BL0175 400 mg

EXPERIMENTAL

Drug: BL0175

BL0175 500 mg

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 100 mg; BL0175 200 mg; BL0175 400 mg; BL0175 50 mg; BL0175 500 mg

Eligibility Criteria

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

You may qualify if:

• Volunteer to participate in the study, be able to understand the requirements of a clinical study, and willingness to sign a written informed consent form.
• Age ≥ 18 years.
• HR-positive, HER2-negative (characterized by the absence of HER2 expression and the presence of ER and/or PR expression) locally advanced or metastatic breast cancer (histological or cytological proven diagnosis) in postmenopausal women with disease progression during or following endocrine therapy, or HR-positive, locally advanced or metastatic ovarian cancer or endometrial cancer in postmenopausal women that progressed during or following prior standard of care therapy.
• Patients with at least one measurable or evaluable lesion: At least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI/plain x-ray at baseline and follow up visit.
• Note: Measurable lesions cannot be selected from the following sites in principle: having received prior radiotherapy or having received other local therapy. If a target lesion at a site that has received prior radiotherapy or other local therapy is the only optional lesion, the progression of the lesion shall be confirmed by the investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
• Life expectancy period ≥ 12 weeks.

You may not qualify if:

• Patients with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.
• Note: patients with treated CNS metastases may participate in this study if the patient has completed radiotherapy or surgery for CNS metastases ≥ 4 weeks prior to study entry, and if the patient is neurologically stable ≥ 2 weeks after radiotherapy or surgery treatment (no new neurologic deficits from brain metastasis on screening clinical examination, no new findings on CNS imaging, and corticosteroids were not required within 2 weeks prior to enrollment).
• Patients who have a history of another primary malignancy (with the exception of participants with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study.
• Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.
• Patients with a history of allogeneic transplantation of organs, bone marrow or stem cell.
• A history of allergic or adverse response(s) to fulvestrant, or prone to allergic reactions (such as: prone to angioedema, urticaria, asthma, rash, etc.).
• Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• New York Heart Association class III-IV for cardiac insufficiency or left ventricular ejection fraction \< 50% (if the LVEF data is available).
• Patients with poorly controlled arrhythmia: QTc interval \> 480 ms calculated by Fridericia's formula, or congenital syndrome of prolonged QT interval.
• Any of the following within 6 months prior to the enrollment: myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism or other clinically significant thromboembolic disease, or coronary artery bypass graft.
• Clinically symptomatic bradycardia as assessed by the investigator.
• Patients with other clinically significant cardiovascular disease who were assessed as unsuitable for this study by the investigator.
• Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive in screening.
• Patients with active hepatitis C or chronic hepatitis B at screening ("active hepatitis" defined as HCV RNA level ≥ 200 IU/mL for hepatitis C or HBV DNA level ≥ 2000 IU/mL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines.
• Active infections requiring antibiotic intravenous therapy within 1 weeks prior to enrollment.

Sponsors & Collaborators

• Shanghai Best-Link Bioscience, LLC: lead

Study Sites (2)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Jinan Central Hospital

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Central Study Contacts

Guat Hoon Ong

CONTACT

+65 9726 6883; gho@zhangjiang-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: March 10, 2025
• Primary Completion: February 20, 2026
• Study Completion (Estimated): December 26, 2027
• Last Updated: January 13, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)