Breast CancerPhase 1NCT06738966
A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
A Phase 1 study testing BL0175 in people with Breast Cancer and Ovarian Cancer, run by Shanghai Best-Link Bioscience, LLC at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Endometrial Cancer
- What is being tested?
- BL0175
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesChina
- Study dates
- 10 Mar 2025to 26 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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.
Who cannot join
- 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.).
Show all 40Show fewer
- 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.
- 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 colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to screening]:
- 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 than 5 half-lives could enroll for their shorter half-life.
- 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 heparin).
- 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: Hormone replacement therapy and symptomatic therapy (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic therapy and are permitted.
- 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 not expected to resolve on their own (e.g., peripheral neuropathy and alopecia) are allowed.
- Those who are determined disqualified to join clinical studies by investigator for other causes.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Haiyan Jia, +86 0431-88782705, jiahaiyan0317@qq.com
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250000
Meili Sun, +86 0531-55865775, smli1980@163.com
About this study
Official title: An International, Multi-Center, Open-label Phase I Study to Evaluate the Tolerance, Pharmacokinetics, and Anti-Tumor Effects of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
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
- Being tested
- BL0175
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL0175Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| BL0175 50 mg | Experimental | Not described Receives: Drug: BL0175 |
| BL0175 100 mg | Experimental | Not described Receives: Drug: BL0175 |
| BL0175 200 mg | Experimental | Not described Receives: Drug: BL0175 |
| BL0175 400 mg | Experimental | Not described Receives: Drug: BL0175 |
| BL0175 500 mg | Experimental | Not described Receives: Drug: BL0175 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Area Under the Plasma Concentration Versus Time Curve (AUC)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to the date of disease progress, usually of 6 months
One year survival rate
Measured: From enrollment to the time of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Mar 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion26 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Best-Link Bioscience, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738966
- Sponsor's protocol ID
- BL0175-102
- Status last verified
- Jul 2025
- First submitted
- 9 Dec 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multi-Center, Open-label Phase I Study to Evaluate the Tolerance, Pharmacokinetics, and Anti-Tumor Effects of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT06738966
- Acronym / sponsor ID
- BL0175-102
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai Best-Link Bioscience, LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 26 Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (40 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL0175BL0175 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. | Drug | BL0175 100 mg, BL0175 200 mg, BL0175 400 mg, BL0175 50 mg, BL0175 500 mg |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment to the end of treatment at 8 weeks
6 secondary outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the date of disease progress, usually of 6 months
One year survival rate
Time frame: From enrollment to the time of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL0175 in people with Breast Cancer and Ovarian Cancer, run by Shanghai Best-Link Bioscience, LLC at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guat Hoon Ong (+65 9726 6883, gho@zhangjiang-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.