[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tasly Biopharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100602844","phase-1-a-safety-tolerability-and-pharmacokinetic-trial-of-multiple-subcutaneous-injections-of-b1344-injection-in-patients-with-nonalcoholic-fatty-liver-diseasenafld-100602844",false,"NCT07128797","a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）","A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Subcutaneous Injections of B1344 Injection in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)","Inclusion Criteria:\n\n1. Chinese patients aged between 18 and 75 years;\n2. Patients diagnosed with NAFLD and with a magnetic resonance proton density fat fraction (MRI-PDFF) ≥10% in the screening\u002Fbaseline period or within one month prior;\n3. Presence of any one of the following metabolic risk factors:\n\n   * Body Mass Index (BMI) ≥24.0 kg\u002Fm² or abdominal obesity (male waist circumference ≥90 cm, female waist circumference ≥85 cm);\n   * Fasting blood glucose ≥6.1 mmol\u002FL, or 2-h blood glucose after glucose load ≥7.8 mmol\u002FL, or glycated hemoglobin (HbA1c) ≥5.7%, or history of type 2 diabetes, or Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) ≥2.5;\n   * Resting blood pressure ≥130\u002F85 mmHg, or currently receiving antihypertensive medication;\n   * Fasting serum triglycerides (TG) ≥1.70 mmol\u002FL, high-density lipoprotein cholesterol (HDL-c) ≤1.0 mmol\u002FL (male) and 1.3 mmol\u002FL (female), or currently receiving lipid-lowering medication.\n4. Weight stability reported by participants within 6 weeks before enrollment (absolute weight change ≤5%).\n5. Participants have no fertility plans within 3 months after signing the informed consent and voluntarily take effective contraceptive measures.\n6. Voluntary participation in the clinical trial, able to sign the informed consent, and capable of understanding and complying with the trial procedures.\n\nExclusion Criteria:\n\n1. Liver biopsy, or clinical diagnosis of cirrhosis based on clinical presentation, biochemical and imaging results, or any of the following criteria: ① FIB-4 score ≥3.48 in the screening\u002Fbaseline period or within 1 month prior, or liver stiffness value (LSM) ≥15 kPa based on FibroScan; ② liver biopsy results indicating NASH-F4 stage within the previous 24 months; ③ clinical examination signs of liver cirrhosis or splenomegaly during the screening\u002Fbaseline period; ④ abdominal imaging results showing liver nodules or splenomegaly during the screening\u002Fbaseline period or within 1 month prior.\n2. History of tumors or liver transplantation, or patients planning to undergo liver transplantation.\n3. History of liver diseases other than NAFLD or clinical suspicion of liver diseases other than NAFLD, including but not limited to secondary NAFLD, hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, alcoholic liver disease, primary sclerosing cholangitis, primary biliary cholangitis, or Wilson's disease.\n4. History of other diabetes besides T2DM (such as type 1 diabetes, secondary diabetes, etc.), or currently using or planning to use insulin, thiazolidinediones, and glucagon-like peptide-1 (GLP-1) analog drugs for treatment.\n5. Presence of other severe, progressive, or uncontrolled diseases besides T2DM, hypertension, and dyslipidemia, including but not limited to immune system, endocrine system, hematologic system, urinary system, hepatobiliary system, respiratory system, nervous system, psychiatric system, cardiovascular system, digestive system, where participation in this trial would increase participant risk as determined by the investigator.\n6. Previous history of weight-loss surgery or plans for weight-loss during the trial, or significant changes in exercise or dietary habits.\n7. History of extra-bone injury, fracture, or bone-related surgery within 2 months before screening.\n8. Participants with a history of long QT syndrome or family history of sudden death, or males with QTcF \\> 450 ms, females with QTcF \\> 470 ms.\n9. Allergic to B1344 or its excipients, or history of allergy to other biological products or severe allergic reactions.\n10. History of drug use related to secondary NAFLD lasting more than 2 weeks within 12 months before screening, including amiodarone, methotrexate, systemic corticosteroids, 5-fluorouracil, irinotecan, tetracycline, tamoxifen, doses exceeding hormone replacement estrogen, anabolic steroids, valproic acid, and other known hepatotoxic drugs.\n11. History of concomitant treatment that does not meet protocol requirements before enrollment, or concomitant treatment that meets protocol requirements but cannot maintain a stable dose until the end of the trial, or plans to initiate new concomitant treatments after the first dose until the end of the trial.\n12. Previous use of FGF-21 analogs or FGFR1 agonists.\n13. Screening\u002Fbaseline examination results meeting the following criteria:\n\n    * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 times the upper limit of normal (ULN), total bilirubin \\>ULN;\n    * Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²;\n    * Hemoglobin \\\u003C120 g\u002FL (male) or \\\u003C110 g\u002FL (female);\n    * HbA1c ≥9%; fasting blood glucose ≥13.9 mmol\u002FL;\n    * International normalized ratio (INR) \\>1.3;\n    * Platelet count \\\u003C110×10⁹\u002FL;\n    * Dual-energy X-ray absorptiometry (DXA) T-score ≤-2.5;\n    * Resting systolic blood pressure \\\u003C90 or ≥160 mmHg, resting diastolic blood pressure \\\u003C50 or ≥100 mmHg;\n    * Resting heart rate \\\u003C60 or \\>100 beats\u002Fminute;\n    * TG ≥5.65 mmol\u002FL;\n    * Hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody (HCVAb) positive, human immunodeficiency virus (HIV) antibody positive, or positive for serum Treponema pallidum specific antibody (TP-Ab).\n14. History of long-term excessive alcohol consumption, or alcohol consumption ≥14 World Health Organization (WHO) alcohol units per week (1 WHO alcohol unit = 10 g pure alcohol) within 3 months before screening, or positive alcohol screening, or unable to refrain from alcohol 48 hours before the first dose until the end of the trial.\n15. Excessive consumption of tea, coffee, or caffeinated beverages (daily consumption of more than 8 cups of respective drinks, with 1 cup being 250 mL) within 3 months before screening, or consumption of any caffeinated food or drink (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours before the first dose.\n16. History of blood donation, loss of blood ≥200 mL, blood transfusion, or use of blood products within 3 months before screening, or plans to donate blood during the trial.\n17. History of needle phobia, blood phobia, or frequent episodes of orthostatic hypotension, or inability to tolerate venipuncture.\n18. History of drug abuse, or positive urine drug abuse screening.\n19. Smoking more than 5 cigarettes daily within the last 3 months or cannot completely quit smoking during the trial.\n20. Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the trial.\n21. Any skin or abdominal wall anomalies that would affect subcutaneous injection, or tattoos or scars covering more than 50% of the abdominal wall surface area.\n22. Participation in other clinical trials and receiving trial interventions within the last 3 months.\n23. Existing MRI examination contraindications or inability to cooperate with MRI examinations before screening.\n24. Other circumstances deemed unsuitable for participation in this trial by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a randomized, double-blind, multicenter, placebo-controlled, multiple-dose escalating clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of B1344 in patients with NAFLD. Additionally, the trial will conduct preliminary observations on the efficacy of B1344, aiming to provide early proof of concept for B1344 as a therapeutic agent for NASH.",[27,28],"NAFLD (Non-alcoholic Fatty Liver Disease)","NASH (Nonalcoholic Steatohepatitis)","RECRUITING","2025-08-18",{"date":32,"type":33},"2025-08-19","ACTUAL",{"date":35,"type":33},"2025-07-24",{"date":37,"type":21},"2026-07",{"name":39,"class":40},"Tasly Biopharmaceuticals Co., Ltd.","INDUSTRY",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100580534","phase-2-a-multicenter-open-phase-iib-clinical-study-to-evaluate-the-efficacy-and-safety-of-b1962-injection-in-the-treatment-of-advanced-colorectal-cancer-100580534","NCT06838546","A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Colorectal Cancer","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be eligible for enrollment in this study:\n\n1. Voluntary participation in the study and provision of signed and dated informed consent;\n2. Aged 18 to 75 years (inclusive) at the time of signing informed consent;\n3. Patients with distant metastasis or unresectable locally advanced colorectal cancer who have disease progression or intolerable toxicities after previous standard treatment must include oxaliplatin, irinotecan and fluorouracil-based drugs in previous standard treatment regimen;\n4. Histologically or cytopathologically confirmed adenocarcinoma of the colon or rectum, including adenocarcinoma of the appendix;\n5. Willingness to comply with protocol-specified visits, study treatment, laboratory tests, and other study-related procedures and requirements;\n6. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;\n7. Expected survival time of more than 3 months;\n8. Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST v1.1 criteria;\n9. Adequate organ and bone marrow function:\n\n   Hematologic system (no transfusion, no G-CSF use, no medication correction within 2 weeks prior to screening): absolute neutrophil count (ANC) ≥ 1.5 × 10 9\u002FL, platelets (PLT) ≥ 75 × 10 9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL; Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0 × ULN, aspartate aminotransferase (AST) ≤ 3.0 × ULN; for patients with liver metastasis: ALT ≤ 5.0 × ULN, AST ≤ 5.0 × ULN; albumin ≥ 30 g\u002FL; Renal function: creatinine within normal range, or creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated according to Cockcroft-Gault formula); Cockcroft-Gault formula is: Ccr (ml\u002Fmin) = \\[(140-age) × weight (kg)× F\\]\u002F\\[serum creatinine (mg\u002Fdl) × 72\\] (F = 1 for males and 0.85 for females) Urine protein was qualitatively 0, ±, or \\\u003C 0.5 g\u002F24 hours. All patients with urine protein(±) in urinalysis must have a 24-hour urine collection and must demonstrate urine protein \\\u003C 0.5 g\u002F24 hours.\n\n   Coagulation: prothrombin time (PT) ≤ 1.5 × ULN or international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Fertile subjects agree to use highly effective contraception from signing the ICF and to avoid pregnancy during the study and for 3 months after the last dose (male or female subjects)\n\n    * Females of childbearing potential must be non-lactating and agree to use highly effective contraception from signing the ICF, and must practice contraception during the study and for 3 months after the last dose; blood pregnancy results (human chorionic gonadotropin hCG) must be negative within 7 days prior to enrollment;\n    * Females of non-childbearing potential (ie, physiologically incapable of becoming pregnant), including those who have been surgically sterilized (having undergone bilateral oophorectomy, bilateral tubal ligation, or hysterectomy), or who have been postmenopausal for ≥ 12 months prior to Screening (amenorrhea not due to treatment).\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from the study:\n\n1. Prior therapy targeting PD- (L) 1 and VEGF\u002FVEGFR, including concurrent use of anti-PD-1\u002FPD-L1 monoclonal antibody in combination with drugs targeting VEGF\u002FVEGFR, or anti-PD-1\u002FVEGF or anti-PD-L1\u002FVEGF bispecific antibodies or bispecific fusion proteins, or sequential use of anti-PD-1\u002FPD-L1 monoclonal antibody and drugs targeting VEGF\u002FVEGFR;\n2. Received the last systemic anti-tumor treatment (biological agent therapy, etc.) within 4 weeks before the first dose, hormone anti-tumor treatment within 2 weeks before the first dose, non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, thalidomide, tumor necrosis factor, etc.) within 2 weeks before the first dose, and received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first dose;\n3. Received systemic anti-tumor therapy in other clinical studies within 4 weeks prior to the first dose;\n4. Radiotherapy or surgery within 4 weeks prior to the first dose and diagnostic biopsy within 7 days prior to the first dose;\n5. Patients who have received live or attenuated vaccines within 4 weeks before screening or plan to receive live or attenuated vaccines during the study;\n6. Known hypersensitivity to the study drug or any of its components, or previous severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies or bispecific antibodies;\n7. Adverse reactions from prior anticancer therapy that have not recovered to NCI-CTCAE v5.0 grade ≤ 1 (except alopecia, etc. for which the investigator considers there is no safety risk);\n8. Prior therapy with ≥ Grade 1 proteinuria, or prior bleeding event ≥ Grade 2 related to drugs targeting VEGF\u002FVEGFR, or prior therapy with ≥ Grade 3 hypertension or ≥ Grade 3 immune-related adverse event.\n9. Known brain and\u002For leptomeningeal metastases;\n10. Patients with pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, or pleural effusion, pericardial effusion or ascites that cannot be controlled by treatment of primary disease, anti-tuberculosis, anti-infection, diuretics or requires repeated drainage once every 3 weeks or more frequently;\n11. Complete or incomplete bowel obstruction or risk of bowel obstruction reported on imaging studies, presence of intra-abdominal abscess, or history of inflammatory bowel disease (eg, Crohn 's disease, ulcerative colitis);\n12. Screening imaging showed tumor encasing vital vessels or obvious necrosis and cavity, and the investigator judged that entering the study would cause bleeding risk, or tumor invading vital organs (such as heart and pericardium, trachea, esophagus) or risk of esophagotracheal fistula or esophagopleural fistula , ulcerated colorectal cancer or tumor infiltrating the full thickness of intestinal wall, or other lesions involving the gastrointestinal tract with bleeding or gastrointestinal fistula and gastrointestinal perforation risk;\n13. Known history of human immunodeficiency virus (HIV) infection (HIV 1\u002F2 antibody positive) or acquired immunodeficiency syndrome-related diseases, or other immunodeficiency diseases;\n14. Positive hepatitis B surface antigen (HBsAg), and HBV DNA higher than the upper limit of normal value of the detection unit; or positive hepatitis C antibody (HCV-Ab) and HCV-RNA quantification \\> the upper limit of normal value of the detection unit; or known active syphilis infection;\n15. Fever of unknown origin \\> 38.5℃; or bacterial, viral, fungal infections and other pathogen infections (such as mycoplasma, parasites, etc.) requiring systemic treatment; or uncontrolled active infections such as tuberculosis;\n16. History of significant cardiovascular disease, including but not limited to: malignant arrhythmia requiring clinical intervention; or acute coronary syndrome (myocardial infarction and angina pectoris) or coronary artery bypass grafting within 6 months before the first dose; or congestive heart failure meeting New York Heart Association (NYHA) functional class II or higher criteria; or left ventricular ejection fraction (LVEF) \\\u003C 50%; poor compliance with standard treatment for hypertension or antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy; major vascular disease (e.g., aortic aneurysm requiring surgery);\n17. Patients suffering from coagulation disorders, bleeding disorders, or other bleeding risks judged by the investigator, such as skin wounds, surgical sites, wound sites, severe mucosal ulcers, fractures, intestinal fistulas without complete healing, or active gastric or duodenal ulcers, gastrointestinal bleeding, esophageal and gastric varices, gastrointestinal perforation within 6 months before the first dose;\n18. Pulmonary hemorrhage\u002Fhemoptysis (daily bleeding\u002Fhemoptysis volume ≥ 2.5ml) within 4 weeks prior to the first dose of study drug;\n19. Arterial or venous thrombosis, or stroke or transient ischemic attack within 6 months prior to the first dose of study drug;\n20. Unstable anticoagulant or thrombolytic therapy within 14 days of the first dose of study drug;\n21. Chronic treatment with aspirin (\\> 325 mg\u002Fday) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function, or thienopyridines such as ticlopidine, clopidogrel, or phosphodiesterase inhibitors such as dipyridamole, cilostazol within 14 days of the first dose of study drug;\n22. Diabetes mellitus and thyroid diseases not stably controlled by drug therapy, such as hyperthyroidism;\n23. Current or past idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, etc.; severe dyspnea, pulmonary insufficiency or continuous oxygen inhalation for any reason;\n24. Active autoimmune diseases or history of autoimmune diseases requiring systemic treatment within 2 years before screening, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis or glomerulonephritis;\n25. Systemic corticosteroid therapy (prednisone \\> 10 mg\u002Fday or equivalent of the same class) or systemic therapy with other immunosuppressive agents within 14 days prior to the first dose of study drug;\n\nExceptions:\n\n1. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid therapy with minimal systemic absorption;\n2. Short-term (≤ 7 days) corticosteroid prophylaxis (eg, allergy to contrast agents) or treatment of non-autoimmune allergic diseases (eg, delayed hypersensitivity caused by contact allergens); 26.Prior organ or hematopoietic stem cell transplant; 27.History of other neoplasms within 5 years prior to screening, except cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, who had undergone successful radical surgery; 28.History of substance abuse or mental disorder; Other serious systemic diseases or laboratory abnormalities or compliance problems or other reasons considered unsuitable for this study by the investigator.",{"count":49,"type":21},80,[51],"PHASE2","This is a multicenter, randomized, open-label, two-stage Phase IIb clinical study to evaluate the efficacy and safety of B1962 in the treatment of advanced colorectal cancer.\n\nThe subjects were patients with distant metastasis or unresectable locally advanced colorectal cancer who had previously failed oxaliplatin, irinotecan, fluorouracil-based drugs therapy containing disease progression or intolerable toxic side effects.\n\nTwo dose groups were investigated:\n\nDose group 1: B1962 35 mg\u002Fkg, intravenous infusion, Q2W, Dose group 2: B1962 45 mg\u002Fkg, intravenous infusion, Q2W.",[54],"Advanced Colorectal Cancer","NOT_YET_RECRUITING","2025-02-17",{"date":58,"type":33},"2025-02-20",{"date":60,"type":21},"2025-02-24",{"date":62,"type":21},"2027-01-31",{"name":39,"class":40},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":64},"100571746","phase-2-a-multicenter-open-label-phase-iia-clinical-study-to-evaluate-the-efficacy-and-safety-of-b1962-injection-in-the-treatment-of-advanced-malignant-solid-tumors-100571746","NCT06724263","A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be eligible for enrollment in this study:\n\n  1. Voluntary participation in the study and provision of signed and dated informed consent;\n  2. Age ≥ 18 years at the time of informed consent;\n  3. Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed or failed to respond to first-line standard therapy, or cannot tolerate standard therapy, or have no standard effective treatment regimen, or refuse standard therapy; and no more than 4 lines of prior systemic anti-tumor therapy. Specific tumor species cohorts were as follows:\n\n     * Recurrent platinum-resistant epithelial ovarian cancer (including primary peritoneal and\u002For fallopian tube cancer): pathologically confirmed ovarian epithelial malignancy, fallopian tube epithelial malignancy, primary peritoneal cancer; and diagnosed platinum-resistant (duration of response to platinum-based therapy is within 6 months after the last dose of platinum-based therapy)\n\n       * Triple-negative breast cancer: pathologically confirmed unresectable locally advanced or metastatic breast cancer with negative ER, PR, and HER-2. ER, PR negativity was defined as: IHC ER \\\u003C 1%, IHC PR \\\u003C 1%. HER-2 negativity is defined as IHC HER-2 (-) or (1 +), and FISH must be performed and the result is negative for HER-2 (2 +) ③ Cervical cancer: pathologically confirmed inoperable locally advanced or metastatic cervical cancer\n\n         * Small-cell lung cancer: histologically or cytologically confirmed, inoperable, locally advanced or metastatic small-cell lung cancer\n\n           ⑤ Biliary Tract Cancer: Pathologically confirmed unresectable locally advanced or metastatic biliary tract cancer, including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma\n\n           ⑥ Hepatocellular carcinoma: pathologically confirmed hepatocellular carcinoma (excluding mixed hepatocellular carcinoma); Barcelona Clinic Liver Cancer (BCLC) stage C, not suitable for radical surgery and\u002For local treatment or stage B without radical progression after surgery and\u002For local treatment; Child-Pugh A liver function; for patients with esophagogastric varices, if gastroscopy or imaging, ultrasound and other examinations suggest severe (G3) varices or positive red sign, indicating high risk of venous bleeding, they are not allowed to participate in this study.\n\n           ⑦ Colorectal cancer: pathologically confirmed unresectable locally advanced or metastatic colorectal cancer\n\n           ⑧ Non-squamous non-small cell lung cancer: pathologically confirmed unresectable locally advanced or metastatic non-squamous non-small cell lung cancer that cannot contain a small cell lung cancer component.\n  4. Willingness to comply with protocol-specified visits, study treatment, laboratory tests, and other study-related procedures and requirements;\n  5. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;\n  6. Expected survival time of more than 3 months;\n  7. Presence of at least one measurable lesion (non radiation therapy field) confirmed by CT or MRI that meets RECIST v1.1 criteria;\n  8. Adequate organ and bone marrow function:\n\n     Hematologic system (no transfusion, no G-CSF use, no medication for correction within 2 weeks prior to screening): absolute neutrophil count (ANC) ≥ 1.5 × 10 9\u002FL, platelets (PLT) ≥ 75 × 10 9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL； Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0 × ULN, aspartate aminotransferase (AST) ≤ 3.0 × ULN; for patients with liver metastasis: ALT ≤ 5.0 × ULN, AST ≤ 5.0 × ULN;\n\n     Renal function:\n\n     i. Creatinine ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated according to Cockcroft-Gault formula \\*);\n\n     \\* Formula is: Ccr (ml\u002Fmin) = \\[(140-age) × weight kg × F\\]\u002F\\[serum creatinine (mg\u002Fdl) × 72\\] (F = 1 for males and 0.85 for females) ii. Urine protein \\\u003C 2 + (ie, 0, ± or 1 +) or proteinuria ≤ 1 g\u002F24 hours Note: All patients with ≥ 2 + urine protein in urinalysis must have a 24-hour urine collection and proteinuria ≤ 1 g\u002F24 hours must be confirmed Coagulation: prothrombin time (PT) ≤ 1.5 × ULN or international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n  9. For female patients:\n\n     Females of childbearing potential, who are not breastfeeding, agree to use highly effective contraception from signing the ICF and use this contraception during the study and for 3 months after the last dose; blood pregnancy results (human chorionic gonadotropin hCG) must be negative within 7 days prior to enrollment; Females of non-childbearing potential (ie, physiologically incapable of becoming pregnant), including those surgically sterilized (having undergone bilateral oophorectomy, bilateral tubal ligation, or hysterectomy), or postmenopausal for ≥ 12 months prior to Screening (amenorrhea not due to treatment);\n  10. Male patients with female partners of childbearing potential must agree to use highly effective contraception starting from signing the ICF and for the duration of the study and for 3 months after the last dose.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from the study:\n\n  1. Prior use of anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody, or other antineoplastic agents containing PD- (L) 1 target;\n  2. Patients who have previously used macromolecular VEGF\u002FVEGFR inhibitors such as bevacizumab, ramucirumab;\n  3. Known hypersensitivity to the study drug or any of its components, or previous severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies or bispecific antibodies;\n  4. Female patients are pregnant or lactating;\n  5. Major surgery within 4 weeks prior to the first dose of study drug, or planned major surgery within the study period; For primary or metastatic liver cancer: local treatment of liver (such as transarterial chemoembolization, transcatheter embolization, hepatic arterial infusion, radiotherapy, radioembolization or radiofrequency ablation, etc.) within 4 weeks prior to the first dose of study drug;\n  6. Adverse reactions from prior anticancer therapy that have not recovered to NCI-CTCAE v5.0 grade ≤ 1 (except alopecia and other for which the investigator considers there is no safety risk);\n  7. Patients with clinical symptoms of brain metastases, spinal cord compression, carcinomatous meningitis, or patients with other evidence of uncontrolled brain or spinal cord metastases (except for stable symptoms and imaging studies showing stable disease for at least 4 weeks before the first dose);\n  8. Patients with clinical symptoms or pleural effusion, pericardial effusion or ascites requiring repeated drainage;\n  9. Screening imaging showed tumor encasing vital blood vessels or obvious necrosis and cavity, and the investigator judged that entering the study would cause bleeding risk; according to anatomical classification of tumor location, diagnosis of central lung cancer, or tumor involving hilum with bleeding risk.\n  10. Known history of human immunodeficiency virus (HIV) infection (HIV 1\u002F2 antibody positive) or acquired immunodeficiency syndrome-related disease;\n  11. Positive hepatitis B surface antigen (HBsAg), and HBV DNA higher than the upper limit of normal value of the detection unit; or positive hepatitis C antibody (HCV-Ab) and HCV-RNA quantification \\> the upper limit of normal value of the detection unit; or known active syphilis infection;\n  12. Uncontrolled bacterial, viral, fungal infections and other pathogen infections (such as mycoplasma, parasites, etc.) requiring systemic treatment within 4 weeks prior to the first dose of study drug;\n  13. History of significant cardiovascular disease, including but not limited to: malignant arrhythmia requiring clinical intervention; or acute coronary syndrome (myocardial infarction and angina pectoris) within 6 months prior to the first dose; or congestive heart failure meeting New York Heart Association (NYHA) functional class II or higher criteria; or left ventricular ejection fraction (LVEF) \\\u003C 50%; poorly controlled hypertension with standard treatment or poor compliance with antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy; and significant vascular disease (eg, aortic aneurysm requiring surgery);\n  14. Patients with coagulation disorders, bleeding disorders, or other conditions judged by the investigator to be at risk of bleeding, such as skin wounds, surgical sites, wound sites, severe mucosal ulcers or fractures that have not healed completely, or active gastroduodenal ulcers, gastrointestinal bleeding, intestinal obstruction, ulcerative colitis, esophagogastric varices, gastrointestinal perforation within 6 months prior to the first dose;\n  15. Pulmonary hemorrhage\u002Fhemoptysis (daily bleeding\u002Fhemoptysis volume ≥ 2.5ml) within 4 weeks prior to the first dose of study drug;\n  16. Biopsy or other minor surgery within 7 days prior to the first dose of study drug, excluding placement of vascular access devices;\n  17. Arterial or venous thrombosis, or stroke or transient ischemic attack within 6 months prior to the first dose of study drug;\n  18. Unstable anticoagulant or thrombolytic therapy within 14 days of the first dose of study drug;\n  19. Chronic treatment with aspirin (\\> 325 mg\u002Fday) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function, or thienopyridines such as ticlopidine, clopidogrel, or phosphodiesterase inhibitors such as dipyridamole, cilostazol within 14 days of the first dose of study drug;\n  20. Diabetes mellitus not stably controlled by drug therapy; thyroid diseases not stably controlled by drug therapy, such as hyperthyroidism;\n  21. Current or previous idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except for local interstitial pneumonia induced by radiotherapy), pulmonary fibrosis, etc.; severe dyspnea, pulmonary insufficiency or continuous oxygen inhalation for any reason;\n  22. Active autoimmune diseases or history of autoimmune diseases requiring systemic treatment within 2 years before screening, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis or glomerulonephritis; Exceptions: hypothyroidism controlled by hormone replacement therapy alone, dermatologic conditions not requiring systemic therapy (eg, vitiligo, psoriasis), controlled celiac disease;\n  23. Systemic corticosteroid therapy (prednisone \\> 10 mg\u002Fday or equivalent of the same class) or systemic therapy with other immunosuppressive agents within 14 days prior to the first dose of study drug; Exceptions include treatment with topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption, or prophylactic short-term (≤ 7 days) use of corticosteroids (eg, allergy to contrast agents), or for the treatment of non-autoimmune conditions (eg, delayed hypersensitivity caused by contact allergens);\n  24. Received the last systemic anti-tumor therapy (biological agent therapy, etc.) within 4 weeks prior to the first dose, chemotherapy or hormone anti-tumor therapy within 2 weeks prior to the first dose, received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, cyclophosphamide, methotrexate, thalidomide, tumor necrosis factor, etc.) within 2 weeks prior to the first dose, and received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose ;\n  25. Prior organ or hematopoietic stem cell transplant;\n  26. History of other neoplasms within 5 years prior to screening, except cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, who had undergone successful radical surgery;\n  27. Has received attenuated vaccines within 4 weeks prior to Screening or plans to receive attenuated vaccines during the study;\n  28. Patients who participated in a clinical study and received study drug within 4 weeks prior to the first dose;\n  29. History of alcohol or drug abuse within 12 months prior to the first dose;\n  30. Known psychiatric disorder that could affect trial compliance;\n  31. Other serious systemic diseases or laboratory abnormalities or other reasons considered unsuitable for this study by the investigator.",{"count":72,"type":21},120,[51],"This is a multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of B1962 in the treatment of ad-vanced solid tumors.\n\nThe study consists of a Screening Period, a Treatment Period, and a Follow-up Period (EOT Visit, Safety Follow-up, and Survival Follow-up).\n\nSubjects who meet the inclusion criteria and do not meet the exclusion criteria at screening will enter the appropriate study co-hort according to tumor type and receive B1962 until unacceptable toxicity, radiographic disease progression, or withdrawal of the sub-ject for other reasons, whichever comes first, for a maximum of 24 months of treatment. Enrollment will be conducted according to three stages: Stage I: It is planned to enroll 5 patients in each of 8 cohorts (tumor type) to observe the safety and efficacy; Stage II: 1 \\~ 2 cohorts are preferred to enroll 15 \\~ 20 patients to observe the ef-ficacy and safety; Stage III: 1 cohort is finally preferred to continue enrollment until a total of no more than 60 patients are observed in this cohort to observe the efficacy and safety.",[76,77,78,79,80,81,82],"Recurrent Platinum-resistant Epithelial Ovarian Cancer","Triple Negative Breast Cancer (TNBC)","Cervical Cancers","Small Cell Lung Cancer","Hepatocellular Carcinoma (HCC)","Colorectal Cancer","Non-Squamous Non-Small Cell Lung Cancer","2024-12-04",{"date":85,"type":33},"2024-12-09",{"date":87,"type":21},"2024-12",{"date":89,"type":21},"2026-08",{"name":39,"class":40},""]