[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Best-Link Bioscience, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,62,83,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100641267","phase-2-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-100641267",false,"NCT07658183","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","A Randomized, Open-Label, Multicenter Phase II 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 Patients","Inclusion Criteria:\n\n1. Voluntary participation in the trial, understanding the specific procedures of the trial, and willing to sign a written informed consent form.\n2. Age ≥ 18 years.\n3. HR positive, HER2 negative, with locally advanced or metastatic breast cancer in postmenopausal patients during or after endocrine therapy.\n4. The blood pregnancy test result during the screening period must be negative (if the postmenopausal state is caused by GnRH agonists).\n5. 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).\n6. At least one measurable lesion exists.\n7. The Eastern Cooperative Oncology Group (ECOG) status score at screening must be ≤ 1.\n8. Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Participants with symptomatic central nervous system (CNS) metastases or cancerous meningitis;\n2. 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).\n3. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.\n4. Participants who have a history of allogeneic transplantation (including but not limited to allogeneic organ, bone marrow, or stem cell transplantation).\n5. A history of allergic to fulvestrant, or prone to allergic reactions (such as prone to angioedema, urticaria, asthma, rash, etc.).\n6. 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) \\\u003C50% (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.\n7. Human immunodeficiency virus (HIV) infection or positive HIV antibody test at screening.\n8. Active hepatitis B (HBV DNA ≥2000 IU\u002FmL) or active hepatitis C (HCV RNA ≥200 IU\u002FmL). Additionally, eligible participants with hepatitis B or C must agree to receive antiviral treatment according to established guidelines; otherwise, they will not be enrolled.\n9. Active infection requiring intravenous antibiotic therapy within 1 week prior to the first administration of the investigational drug.\n10. Moderate or severe hepatic impairment, defined as meeting Child-Pugh classification criteria B or C.\n11. 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) \\\u003C1.5×10⁹\u002FL; 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) \\\u003C90 g\u002FL; Platelet count (PLT) \\\u003C100×10⁹\u002FL; International Normalized Ratio (INR) \\>1.5 (for patients on anticoagulant therapy, values within therapeutic range are acceptable); Creatinine clearance \\\u003C30 mL\u002Fmin.\n12. 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).\n13. 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).\n14. Severe vascular embolic events requiring medical or surgical intervention.\n15. Active autoimmune diseases requiring systemic treatment (including use of immunomodulatory agents, corticosteroids, or immunosuppressive drugs).\n\n    Note: Patients with hyperthyroidism\u002Fhypothyroidism are eligible for enrollment. Hormonal replacement therapy and symptomatic treatments (e.g., levothyroxine for adrenal or pituitary insufficiency, insulin, or physiologic corticosteroid replacement) are not considered forms of systemic therapy and are permitted.\n16. Received systemic corticosteroids within 4 weeks prior to the first administration of the investigational medicinal product (except low-dose corticosteroids, such as ≤20 mg prednisone per day or equivalent).\n17. Underwent major surgery within 4 weeks prior to the first administration of the investigational medicinal product, or planned to undergo major surgery during the study period.\n18. Currently pregnant or breastfeeding, or expected to become pregnant during the study period (from screening visit through 2 years after the last dose of study treatment).\n19. Not recovered from toxicity related to prior treatment (including prior immunotherapy) and\u002For complications from surgical interventions to a CTCAE v6.0 grade ≤1.\n\n    Note: Participants with stable chronic adverse events (≤grade 2) that are not expected to resolve spontaneously (e.g., peripheral neuropathy and alopecia) are allowed.\n20. Any other condition deemed unsuitable for participation in this trial by the investigator.","FEMALE","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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:\n\n1. Which dose level of BL0175 demonstrates the optimal ORR?\n2. What is the recommended phase 3 dose (RP3D) based on efficacy and safety data across the tested dose levels?",[26],"Breast Cancer (Locally Advanced or Metastatic)","NOT_YET_RECRUITING","2026-06-16",{"date":30,"type":31},"2026-06-18","ACTUAL",{"date":33,"type":20},"2026-07-20",{"date":35,"type":20},"2028-05-31",{"name":37,"class":38},"Shanghai Best-Link Bioscience, LLC","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":46,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100635296","phase-1-a-clinical-study-for-the-safety-and-efficacy-of-bl0020-injection-in-combination-with-toripalimab-injection-in-patients-with-recurrent-extensive-stage-small-cell-lung-cancer-100635296","NCT07550842","A Clinical Study for the Safety and Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer","An Open, Multi-center Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. 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.\n2. Aged ≥ 18 years, male or female.\n3. Patients with histologically or cytologically confirmed ES-SCLC (per the American Veterans Administration Lung Study Group \\[VALG\\] staging system) who have relapsed or progressed following first-line platinum-based systemic treatment regimen.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.\n5. Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Chemotherapy-free interval (CTFI: time from the last dose of first-line platinum-based chemotherapy to disease progression) \\\u003C 30 days, regardless of maintenance treatment with immune checkpoint inhibitors.\n2. Histologically or cytologically confirmed combined SCLC and transformed SCLC.\n3. Patients with central nervous system (CNS) metastases or carcinoma meningitis. Note: Patients with asymptomatic CNS metastases may participate in this study if they meet all the following criteria:\n\n1)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 ≥ 4 weeks after radiotherapy or surgery treatment (no new neurologic deficits from brain metastasis on screening clinical examination, no new findings on CNS imaging, and high doses of corticosteroids \\[\\> 10 mg prednisone daily or equivalent\\] were not required within 4 weeks prior to screening).\n\n2)Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord).\n\n4.Previous or current autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the following allowed exceptions:\n\n1. Patients with a history of autoimmune-related hypothyroidism on thyroid replacement hormone therapy.\n2. Patients with controlled Type I diabetes mellitus on an insulin regimen.\n3. Patients with vitiligo. 5.Patients with Gilbert's syndrome disease. 6.Patients who have a history of another primary malignancy (with the exception of patients 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.\n\n7.Poorly controlled hypertension (defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy.\n\n8.Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive during screening.\n\n9.Active hepatitis C or chronic hepatitis B at screening (\"active hepatitis\" defined as HCV RNA ≥ ULN at the local clinical site for hepatitis C, or HBV DNA ≥ ULN at the local clinical site for hepatitis B). Note: Antiviral therapy may be administered during the study to prevent viral reactivation if necessary.\n\n10.Patients who have not sufficient baseline organ function. 11.Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine) within 4 weeks before enrollment or scheduled to receive during the study.\n\n12.Known allergy to Toripalimab, BL0020, or any of their excipients. 13.Pregnant or lactating women. 14.Patients who are assessed disqualified to join clinical studies by investigator due to any causes.","ALL",{"count":48,"type":20},33,[50],"PHASE1","Lung cancer remains the leading cause of cancer deaths worldwide; in 2022, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. Globally, lung cancer is the leading cause of cancer-related deaths in men and the second leading cause in women after breast cancer. Among them, small cell lung cancer (SCLC) accounts for approximately 14% of all newly diagnosed lung cancers. Small cell lung cancer (SCLC) is a highly heterogeneous and aggressive disease with poor survival outcomes.\n\nA 2-stage system dividing patients into limited and extensive disease was developed in 1973 by the United States (US) Veteran's Administration Lung Cancer Study Group (VALG), which has been used to this day. Patients with limited-stage SCLC can be treated with chemotherapy and radiation with the potential for long-term survival. However, the majority (approximately 70%) of patients with SCLC are diagnosed with extensive-stage SCLC (ES-SCLC), which has poor survival prospects. Chest pain, dyspnea, and cough are among the most frequent disease-related symptoms experienced by patients with SCLC. Immune checkpoint inhibitors in combination with platinum-based systemic therapy can palliate symptoms and prolong survival for patients with ES-SCLC. However, long-term survival is rare.\n\nThe current standard first-line treatment for patients with ES-SCLC is immune checkpoint inhibitors in combination with platinum-based systemic therapy. Despite the impressive high objective response rates (approximately 60%-80%) observed with first-line treatment regimens, the median overall survival (OS) of patients rarely exceeds 16 months, and the median progression-free survival (PFS) is also limited to around 5 months. Second-line and subsequent therapeutic options are limited. The main treatment drugs include Topotecan, Lurbinectedin, Tarlatamab, etc., with objective response rates rarely exceeding 40%. Therefore, there is a significant need for improved novel treatment options for patients with ES-SCLC.\n\nThis is a multi-center, open-label study. The study is designed to evaluate the safety, tolerability, and preliminary efficacy of Toripalimab in combination with BL0020 in patients with ES-SCLC who have relapsed or progressed following first-line platinum-based systemic treatment regimen.",[53],"Small Cell Carcinoma of Lung","2026-04-20",{"date":56,"type":31},"2026-04-24",{"date":28,"type":20},{"date":59,"type":20},"2028-08-18",{"name":37,"class":38},8,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":46,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100624845","phase-1-a-clinical-study-for-the-efficacy-and-safety-of-bl0020-injection-in-patients-with-small-cell-lung-cancer-transformed-from-non-small-cell-lung-cancer-following-egfr-tki-therapy-100624845","NCT07414927","A Clinical Study for the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy","An Open-Label, Single-Arm Phase I\u002FII Clinical Study to Evaluate the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy","Inclusion Criteria:\n\n1. 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.\n2. Aged ≥ 18 years, male or female.\n3. Patients with initial diagnosis of EGFR-mutated NSCLC and histologically or cytologically confirmed transformation to SCLC following treatment with EGFR tyrosine kinase inhibitor.\n4. After transformation to SCLC, the patient's prior treatment history must meet one of the following criteria:\n\n   * Progression after only receiving platinum-based treatment regimens.\n   * No prior systemic therapy for SCLC.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.\n6. Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Patients with symptomatic brain metastases or carcinoma meningitis. Note:\n\n   * Patients with treated brain metastases may participate in this study if the patient has completed radiotherapy or surgery for brain metastases ≥ 4 weeks prior to study entry, and neurologically stable ≥ 4 weeks after radiotherapy or surgery treatment \\[i.e., no new findings on brain imaging and no new neurologic deficits from brain metastasis on screening examination, and high doses of corticosteroids (\\> 10 mg prednisone daily or equivalent) were not required within 4 weeks prior to enrollment\\].\n   * Patients with brainstem metastases or spinal cord compression (detected by radiographic imaging, even if they did not have symptoms) were not eligible.\n2. Patients who have a history of another primary malignancy (with the exception of patients 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.\n3. Patients with tumors that had invaded important blood vessels as shown in the screening imaging and that the investigators assessed were highly likely to cause fatal bleeding during the study.\n4. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.\n5. Patients with Gilbert's syndrome disease.\n6. Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive during screening.\n7. Patients with active hepatitis C or chronic hepatitis B at screening (\"active hepatitis\" defined as HCV RNA level ≥ 200 IU\u002FmL for hepatitis C or HBV DNA level ≥ 2000 IU\u002FmL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines.\n8. Patients who have not sufficient baseline organ function.\n9. Those who are known to be allergic to the active ingredient or excipients of the investigational product BL0020 Injection, or who have a predisposition to allergy.\n10. Patients who are taking anticoagulant therapy (prophylactic use of low-dose aspirin \\[≤ 100 mg\u002Fday\\] or low molecular weight heparin is allowed).\n11. Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before enrollment or scheduled to receive during the study.\n12. Pregnant or lactating women.\n13. Patients who are assessed disqualified to join clinical studies by investigator due to any causes.",{"count":70,"type":20},48,[50,23],"The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). After a certain period of treatment with EGFR TKI, acquired resistance emerges most frequently with a secondary mutation, p.T790M, followed by MET amplification. Interestingly, up to 3-14% of patients experience histological transformation into small cell lung cancer (SCLC), which has an aggressive clinical course and a poor prognosis.\n\nThe transformed SCLC retains the original EGFR mutation but significantly down regulates EGFR protein expression, eliminating its dependence on EGFR signaling while simultaneously acquiring a neuroendocrine phenotype. In nearly all cases, bi-allelic inactivation of both TP53 and RB1 is observed. However, little is known about the clinical outcomes of transformed SCLC, with limited studies arguing that their outcomes are similar to those of de novo SCLC, where the median overall survival is approximately 9 to 10 months after the transformation.\n\nAt present, there is no standard treatment regimen for patients with SCLC transformed from NSCLC following EGFR TKI therapy.\n\nBL0020 is a polymer-drug conjugate consisting of Topoisomerase I inhibitor SN-38 (7-ethyl-10-hydroxycamptothecin) conjugated by a peptide linker to a PEG-modified poly(ε-L-lysine) polymer. In the ongoing first-in-human study of BL0020, significant efficacy has been observed with BL0020 monotherapy in SCLC patients who have relapsed or progressed following at least first-line platinum-based systemic treatment.\n\nBased on previous clinical and preclinical outcomes that show similar disease characteristics between SCLC transformed from NSCLC following EGFR TKI therapy and de novo SCLC, this study is designed to evaluate the clinical efficacy and safety of BL0020 in patients with transformed SCLC.",[53],"2026-02-14",{"date":76,"type":31},"2026-02-17",{"date":78,"type":20},"2026-03-27",{"date":80,"type":20},"2028-02-20",{"name":37,"class":38},1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100621131","phase-1-a-study-of-single-dose-of-bl0175-in-postmenopausal-women-100621131","NCT07366632","A Study of Single Dose of BL0175 in Postmenopausal Women","A Phase I, International, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of BL0175 Injection Compared With a Single Dose of Fulvestrant Injection in Postmenopausal Women","Inclusion Criteria:\n\n1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form.\n2. Postmenopausal female participants aged ≥ 18 years old.\n3. Body weight ≥ 45kg and body mass index (BMI= weight\u002Fheight2) scores ≥ 18 kg\u002Fm2 and ≤ 35 kg\u002Fm2.\n4. Participants with laboratory tests, physical examinations, vital signs, and electrocardiogram (ECG) results judged by the investigator as normal or abnormal with no clinical significance (NCS).\n\nExclusion Criteria:\n\n1. Participants with a history or current presence of any cardiovascular, gastrointestinal, endocrine, hematological, hepatic, immunological, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal, and\u002For other major diseases that are considered clinically significant by the investigator.\n2. A history of allergy to fulvestrant, alcohol, castor oil, benzyl alcohol, benzyl benzoate or any other comparable or similar products, or prone to allergic reactions (such as: prone to angioedema, urticaria, asthma, rash, etc.), or history of allergy to two or more drugs (or foods).\n3. Participants with current concomitant sciatica, neuralgia, or peripheral neuropathy.\n4. History of allogeneic transplantation of organs, bone marrow or stem cell.\n5. Active infection, a known history of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection or screening for infectious disease (HBsAg, hepatitis C virus antibody \\[HCV-Ab\\], or human immunodeficiency virus antigen\u002Fantibody \\[HIV-Ag\u002FAb\\]) during the screening period is positive.\n6. Unable to refrain from or anticipate the use of any prescription medications not for the treatment of concomitant diseases within 4 weeks prior to administration, or any over-the-counter drugs (including but not limited to Chinese herbal medicines, compound preparations of Chinese herbal medicines, health products, etc.) not for the treatment of concomitant diseases within 2 weeks prior to administration.\n7. Participants who are vaccinated within 14 days prior to dosing administration.\n8. Those who donated plasma or blood within 12 weeks prior to the dosing administration or donated or lost blood 400 mL or more within 12 weeks prior to the dosing administration, or plan to donate during the study.\n9. Any history of coagulation dysfunction, bleeding diathesis (e.g., disseminated intravascular coagulation, coagulation factor deficiencies), long-term anticoagulant therapy (excluding antiplatelet therapy and low-dose warfarin), active bleeding (such as gastrointestinal bleeding), or clinically significant thrombocytopenia.\n10. Intolerance to \u002F fear of venipuncture, needles, or blood collection difficulties (such as poor vascular conditions, fear of blood collection, needle dizziness, etc.).\n11. Those who underwent major surgery within 4 weeks before screening, or plan to undergo major surgery during the study.\n12. Those who have taken\u002Fused investigational drugs, vaccines or devices within the 4 weeks or 5 half-lives of investigational drug (whichever is longer) prior to the dosing administration.\n13. Participants who with a history of alcoholism, or with a history of alcohol abuse within 3 months prior to screening (by self-declaration) \\> 14 alcohol units per week (1 alcohol unit is about equal to 50° white wine 35 mL or 5° beer 350 mL or wine 150 mL). Participants are unable\u002Funwilling to refrain from alcohol, or strenuous exercise 48 hours prior to each study visit.\n14. Participants who with a history of drug abuse or drug dependence, or those who have used illicit drugs within 1 year prior to screening.\n15. Positive alcohol or drug screen results at Baseline.\n16. Those who are determined by the investigator to be ineligible for other reasons.",true,{"count":92,"type":20},27,[50],"The goal of this clinical trial is to learn the safety and PK of the single dose of BL0175 Injection in postmenopausal women and to compare that with a single dose of Fulvestrant Injection. The main questions it aims to answer are:\n\n* What medical problems do participants have when using drug BL0175?\n* How long can BL0175 remain in your blood? Participants will receive a single dose of drug BL0175 or a single dose of Fulvestrant Injection in a randomized method",[96],"Postmenopausal Women","2026-01-16",{"date":99,"type":31},"2026-01-26",{"date":99,"type":20},{"date":102,"type":20},"2026-12-21",{"name":37,"class":38},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":46,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100572876","phase-1-a-study-of-bl0175-injection-in-postmenopausal-female-adults-with-hr-positive-locally-advanced-or-metastatic-cancer-100572876","NCT06738966","A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer","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","Inclusion Criteria:\n\n1. 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.\n2. Age ≥ 18 years.\n3. HR-positive, HER2-negative (characterized by the absence of HER2 expression and the presence of ER and\u002For 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.\n4. Patients with at least one measurable or evaluable lesion: At least one lesion (measurable and\u002For non-measurable) that can be accurately assessed by CT\u002FMRI\u002Fplain x-ray at baseline and follow up visit.\n\n   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.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.\n6. Life expectancy period ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Patients with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.\n\n   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).\n2. 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.\n3. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.\n4. Patients with a history of allogeneic transplantation of organs, bone marrow or stem cell.\n5. A history of allergic or adverse response(s) to fulvestrant, or prone to allergic reactions (such as: prone to angioedema, urticaria, asthma, rash, etc.).\n6. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n\n   * New York Heart Association class III-IV for cardiac insufficiency or left ventricular ejection fraction \\\u003C 50% (if the LVEF data is available).\n   * Patients with poorly controlled arrhythmia: QTc interval \\> 480 ms calculated by Fridericia's formula, or congenital syndrome of prolonged QT interval.\n   * 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.\n   * Clinically symptomatic bradycardia as assessed by the investigator.\n   * Patients with other clinically significant cardiovascular disease who were assessed as unsuitable for this study by the investigator.\n7. Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive in screening.\n8. Patients with active hepatitis C or chronic hepatitis B at screening (\"active hepatitis\" defined as HCV RNA level ≥ 200 IU\u002FmL for hepatitis C or HBV DNA level ≥ 2000 IU\u002FmL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines.\n9. Active infections requiring antibiotic intravenous therapy within 1 weeks prior to enrollment.\n10. Moderate or severe hepatic impairment (Child-Pugh class B or C).\n11. 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\\]:\n\n    * Absolute Neutrophil Count (ANC) \\\u003C 1.5×109\u002FL.\n    * Total bilirubin \\> 1.5×ULN.\n    * 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.\n    * Hemoglobin \\\u003C 90 g\u002FL.\n    * Platelets \\\u003C 100×109 \u002FL.\n    * Creatinine clearance \\\u003C 30 mL\u002Fmin.\n12. Prior to first dose of the investigational product, received an antitumor drug or investigational drug at the following time intervals:\n\n    * 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.\n    * 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.\n    * Monoclonal antibodies ≤ 28 days for anticancer therapy.\n    * Anti-tumor Chinese medicine which approved by the agency ≤ 14 days.\n    * Immunosuppressive therapy for any reason ≤ 7 days.\n    * Fulvestrant ≤ 250 days (5 half-lives).\n    * All other investigational drugs or devices ≤ 28 days or 5 half-lives before the first dosing administration (whichever is shorter).\n13. 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).\n14. Severe vascular embolism events requiring medical or surgical intervention.\n15. Active autoimmune diseases that require systemic treatment (i.e. use of immunomodulators, corticosteroids, or immunosuppressive drugs).\n\n    Note: Participants with hyperthyroidism\u002Fhypothyroidism 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.\n16. 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).\n17. Those who underwent major surgery within 4 weeks before enrollment, or plan to undergo major surgery during the study.\n18. Has not recovered from the toxic effects of prior treatment (including prior immunotherapy) and\u002For complications of surgical intervention to CTCAE v5.0 ≤ 1.\n\n    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.\n19. Those who are determined disqualified to join clinical studies by investigator for other causes.",{"count":112,"type":20},9,[50],"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:\n\n* Does the investigational drug BL0175 is safe for participants after dosed -multiple times?\n* Which is the highest safety dose of BL0175 after multiple dose?\n* What medical problems do participants have when using BL0175?\n* Does the investigational drug BL0175 works for participants after dosed -multiple times?",[116,117,118],"Breast Cancer","Ovarian Cancer","Endometrial Cancer","RECRUITING","2026-01-12",{"date":122,"type":31},"2026-01-13",{"date":124,"type":31},"2025-03-10",{"date":126,"type":20},"2027-12-26",{"name":37,"class":38},2,""]