Tiny drug particles aim to target tough breast, ovarian, and endometrial cancers
NCT ID NCT06738966
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing an experimental drug called BL0175, a nano-medicine designed to deliver treatment directly into tumors. It is for postmenopausal women with advanced or metastatic hormone-receptor-positive breast, ovarian, or endometrial cancer that has progressed after hormone therapy. The main goals are to check the drug's safety, find the highest safe dose, and see if it can slow cancer growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BL0175 (a nano-medicine that delivers an estrogen receptor down regulator directly into tumors)
- What this could lead to
- If it works, this could point toward a new treatment option for hormone-receptor-positive cancers that have stopped responding to standard hormone therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 9 participants, so safety and effectiveness are not yet known. The drug may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Age ≥ 18 years. 3. 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. 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening. 6. Life expectancy period ≥ 12 weeks. Exclusion Criteria: 1. 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). 2. 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. 3. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention. 4. Patients with a history of allogeneic transplantation of organs, bone marrow or stem cell. 5. A history of allergic or adverse response(s) to fulvestrant, or prone to allergic reactions (such as: prone to angioedema, urticaria, asthma, rash, etc.). 6. 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. 7. Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive in screening. 8. 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. 9. Active infections requiring antibiotic intravenous therapy within 1 weeks prior to enrollment. 10. Moderate or severe hepatic impairment (Child-Pugh class B or C). 11. 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. 12. 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). 13. 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). 14. Severe vascular embolism events requiring medical or surgical intervention. 15. 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. 16. 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). 17. Those who underwent major surgery within 4 weeks before enrollment, or plan to undergo major surgery during the study. 18. 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. 19. Those who are determined disqualified to join clinical studies by investigator for other causes.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jinan Central Hospital
RECRUITINGJinan, Shandong, 250000, China
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The First Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130000, China
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