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Official title A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
ClinicalTrials.gov ID: NCT06738966
What this study is testing
What is BL0175?
BL0175 is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Patients with at least one measurable or evaluable lesion: At least one lesion (measurable and/or non-measurable) that can be accurately assessed by...
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
You likely can't join if
- Patients with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis. Note: patients with treated CNS metastases may...
- Patients who have a history of another primary malignancy (with the exception of participants with cured basal cell carcinoma of the skin, squamous...
- 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...
- Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
See the full eligibility criteria
Who can join
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
- Life expectancy period ≥ 12 weeks.
What rules you out
- 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...
- 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...
- 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...
- 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...
- Active infections requiring antibiotic intravenous therapy within 1 weeks prior to enrollment.
- Moderate or severe hepatic impairment (Child-Pugh class B or C).
- Patients who have not sufficient baseline organ function and whose laboratory data meet the following criteria at enrollment [No transfusion of blood products (including platelets or red blood cells) or use of...
- Absolute Neutrophil Count (ANC) \< 1.5×109/L.
- Total bilirubin \> 1.5×ULN.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3×ULN without liver metastases or primary liver cancer. AST or ALT \> 5×ULN if the patient has documented liver metastases.
- Hemoglobin \< 90 g/L.
- Platelets \< 100×109 /L.
- Creatinine clearance \< 30 mL/min.
- Prior to first dose of the investigational product, received an antitumor drug or investigational drug at the following time intervals:
- Chemotherapy, targeted small molecule therapy or radiotherapy (except palliative radiotherapy and the radiotherapy area do not include the proposed target lesion) ≤ 14 days. The wash-out period for TKI drugs is more...
- Immunotherapy or cell therapy (i.e. chimeric antigen receptor T cell therapy) ≤ 28 days; Other cell therapy must be discussed with the investigators to determine eligibility.
- Monoclonal antibodies ≤ 28 days for anticancer therapy.
- Anti-tumor Chinese medicine which approved by the agency ≤ 14 days.
- Immunosuppressive therapy for any reason ≤ 7 days.
- Fulvestrant ≤ 250 days (5 half-lives).
- All other investigational drugs or devices ≤ 28 days or 5 half-lives before the first dosing administration (whichever is shorter).
- Bleeding constitution (e.g., diffuse intravascular coagulation [DIC], clotting factor deficiency), or long-term anticoagulant therapy (excluding antiplatelet therapy and low doses of warfarin and low molecular weight...
- Severe vascular embolism events requiring medical or surgical intervention.
- Active autoimmune diseases that require systemic treatment (i.e. use of immunomodulators, corticosteroids, or immunosuppressive drugs). Note: Participants with hyperthyroidism/hypothyroidism could participate. Note...
- Those who have received systemic corticosteroids within 4 weeks prior to administration of BL0175 or active control (low doses of corticosteroids are excluded, such as ≤ 20 mg prednisone daily or equivalent).
- Those who underwent major surgery within 4 weeks before enrollment, or plan to undergo major surgery during the study.
- Has not recovered from the toxic effects of prior treatment (including prior immunotherapy) and/or complications of surgical intervention to CTCAE v5.0 ≤ 1. Note: Participants with stable chronic AE (≤ grade 2) that are...
- Those who are determined disqualified to join clinical studies by investigator for other causes.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China; Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.