[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sichuan Baili Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":489},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,96,0,25,[9,44,62,86,106,125,142,161,179,201,221,238,256,274,291,310,328,345,363,382,400,417,434,451,469],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100652820","phase-1-a-study-of-bl-m08d-in-patients-with-locally-advanced-or-metastatic-digestive-tract-tumors-and-other-solid-tumors-100652820",false,"NCT07780318","A Study of BL-M08D in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic gastrointestinal tumors and other solid tumors;\n6. Agree to provide archival tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy results being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;\n15. The trial participant is capable and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe cardiac or cerebrovascular disease;\n3. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of another malignant tumor within 5 years prior to the first dose;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension inadequately controlled by antihypertensive medication;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease requiring hormone therapy, or current ILD, or radiation pneumonitis of Grade ≥2;\n10. Severe impairment of respiratory function;\n11. Active central nervous system metastases;\n12. Previous or concurrent central nervous system disorders;\n13. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;\n14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n15. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n16. Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration;\n17. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n18. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, cervical, or other regions;\n19. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n20. Pregnant or breastfeeding women;\n21. Other conditions deemed by the investigator to make the patient unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This Phase Ib\u002FII study is a clinical trial exploring the efficacy and safety of BL-M08D1 for injection in patients with locally advanced or metastatic digestive tract tumors and other solid tumors.",[29,30],"Digestive Tract Tumors","Solid Tumors","NOT_YET_RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":22},"2026-09",{"date":39,"type":22},"2028-12",{"name":41,"class":42},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":61,"locationsCount":43},"100652869","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-gynecological-tumors-and-other-solid-tumors-100652869","NCT07778862","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Gynecological Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Gynecological Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic gynecological tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test being negative, and they must not be lactating; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion;\n15. Trial participants must be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, or other treatments within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive drug therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior occurrence of ≥ Grade 3 toxicity related to anti-angiogenic therapy when receiving such therapy previously;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Poorly controlled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe respiratory impairment;\n13. Active central nervous system metastases;\n14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036;\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n18. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n19. Imaging findings indicating tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;\n20. Trial participants with clinically significant bleeding or significant bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or breastfeeding women;\n24. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.",{"count":52,"type":22},30,[25],"This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic gynecological tumors and other solid tumors.",[56,30],"Gynecological Tumors","2026-08-18",{"date":34,"type":35},{"date":37,"type":22},{"date":39,"type":22},{"name":41,"class":42},{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":69,"targetDuration":4,"studyType":23,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100474735","phase-1-a-study-of-bl-m07d1-in-patients-with-locally-advanced-or-metastatic-her2-positivelow-expression-breast-cancer-and-other-solid-tumors-100474735","NCT05461768","A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2-Positive\u002FNegative Breast Cancer and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-Positive\u002FNegative Breast Cancer and Other Solid Tumors","Inclusion Criteria:\n\n* 1\\. Sign the informed consent voluntarily and follow the program requirements\n* 2\\. No gender limitation;\n* 3\\. Age: ≥18 years old and ≤75 years old (Stage Ia);≥18 years old (Ib);\n* 4\\. Expected survival time ≥3 months;\n* 5\\. Inoperable locally advanced or metastatic HER2-positive\u002Flow-expression breast cancer and other solid tumors that have been histopathologically and\u002For cytologically confirmed and have failed standard therapy, or are not available for standard therapy, or are not currently eligible for standard therapy; HER2 positive: IHC3+, or IHC2+ and ISH positive; HER2 low expression: IHC2+ and ISH negative, or IHC1+;\n* 6\\. Agree to provide archived tumor tissue samples or fresh tissue samples from the primary tumor or metastatic tumor within 2 years (to detect the expression of HER2 protein in tumor pathological tissue and explore the correlation between HER2 protein and bl-M07D1 validity index); If subjects are unable to provide tumor tissue samples, they will be admitted after evaluation by the investigator if other admission criteria are met.\n* 7\\. Must have at least one measurable lesion as defined by RECIST V1.1;\n* 8\\. ECOG score of 0 or 1;\n* 9\\. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (the investigator considered asymptomatic laboratory abnormalities, such as elevated ALP, hyperuricemia, and elevated blood glucose, etc.); Except for toxicity that the investigator judged to have no safety risk, such as alopecia, pigmentation, grade 2 peripheral neurotoxicity, etc.);\n* 10\\. No serious cardiac dysfunction, left ventricular ejection fraction ≥50%;\n* 11\\. Organ function level must meet the following requirements and meet the following standards: A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count ≥90×10\\^9\u002FL, hemoglobin ≥90 g\u002FL; B) Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis; C) Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL\u002Fmin (according to the Cockcroft and Gault formula).\n* 12\\. Coagulation function: International standardized ratio (INR) ≤1.5, and activated partial thrombin time (APTT) ≤1.5ULN;\n* 13\\. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n* 14\\. For premenopausal women at risk of fertility, pregnancy tests must be performed within 7 days prior to the start of treatment. Serum\u002Furine pregnancy must be negative and must be non-lactation; All enrolled patients (male and female) should use adequate barrier contraception throughout the treatment cycle and 6 months after the end of treatment\n\nExclusion Criteria:\n\n* 1\\. Prior use of chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery (as defined by the investigator), targeted therapy (including small molecule tyrosine kinase inhibitors) and other antitumor therapies within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing; Mitomycin and nitrosourea were administered within 6 weeks prior to initial administration; For oral fluorouracil drugs such as gio, capecitabine, or palliative radiotherapy within 2 weeks before initial administration; The Chinese medicine with anti-tumor indication was given within 2 weeks before the first administration.\n* 2\\. Prior ADC treatment (phase Ib only) with the toxin of camptothecin derivatives (topoisomerase I inhibitors);\n* 3\\. History of severe heart disease, such as symptomatic congestive heart failure (CHF) grade 2 or greater (CTCAE 5.0), NYHA grade 2 or greater heart failure, history of transmural myocardial infarction, unstable angina, etc.;\n* 4\\. QT prolongation (male QTc \\> 450 msec or female QTc \\> 470 msec), complete left bundle branch block, III atrioventricular block;\n* 5\\. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, systemic treatment of psoriasis, rheumatoid arthritis, inflammatory bowel disease, and hashimoto's thyroiditis, etc., with the exception of type I diabetes, only replacement therapy can control the hypothyroidism, no systemic treatment of skin disease (e.g., vitiligo, psoriasis);\n* 6\\. Other malignancies diagnosed within 5 years prior to first administration, except for radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radical resected carcinoma in situ;\n* 7\\. Screening for unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within the first 6 months; Infusion device-related thrombosis is excluded;\n* 8\\. Patients with poorly controlled pleural effusion with clinical symptoms were judged by researchers to be unsuitable for inclusion;\n* 9\\. Hypertension poorly controlled by medications (systolic \\& GT; 150 mmHg or diastolic pressure \\& GT; 100 mmHg);\n* 10\\. According to CTCAE V5.0, patients were defined as ≥3 grade of lung disease, ≥2 grade of radioactive lung disease, existing or with a history of ILD;\n* 11\\. Symptoms of active CNS metastasis. But the researchers concluded that patients with stable parenchymal metastases could be included. The definition of stability must meet the following four requirements: A. Seizureless state lasting \\> 12 weeks with or without antiepileptic drugs; B. Glucocorticoids are not required; C. Two consecutive MRI scans (at least 4 weeks between scans) showed stable imaging state; D. Asymptomatic patients have been stable for more than 1 month after treatment;\n* 12\\. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of BL-M07D1;\n* 13\\. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (ALLO-HSCT);\n* 14\\. Equivalent cumulative dose of doxorubicin in anthracycline adjuvant therapy was \\> 360 mg\u002Fm\\^2;\n* 15\\. Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \\> lower limit) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA \\> lower limit);\n* 16\\. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.\n* 17\\. Participated in another clinical trial within 4 weeks prior to initial administration (starting from the time of last administration);\n* 18\\. Pregnant or nursing women;\n* 19\\. Other conditions considered inappropriate for participation in this clinical trial by the investigator",{"count":70,"type":22},348,[25],"In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive\u002Flow-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1.\n\nIn phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.\n\nIn addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients",[74,75],"Breast Cancer","Locally Advanced or Metastatic Solid Tumor","RECRUITING","2026-08-14",{"date":79,"type":35},"2026-08-17",{"date":81,"type":35},"2022-08-09",{"date":83,"type":22},"2027-12",{"name":41,"class":42},7,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":93,"minAge":18,"maxAge":19,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":43},"100652096","phase-2-a-study-of-bl-m09d1-in-patients-with-locally-advanced-or-metastatic-gynecological-malignancies-and-other-solid-tumors-100652096","NCT07769229","A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors","A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. Female;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Diagnosed with endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma, or other solid tumors;\n6. Patients with locally advanced or metastatic gynecological malignancies and other solid tumors who have failed standard treatment or are intolerant to standard treatment;\n7. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;\n8. Must have at least one measurable lesion as defined by RECIST v1.1;\n9. Eastern Cooperative Oncology Group performance status of 0 or 1;\n10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n12. Organ function levels must meet the protocol requirements;\n13. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n14. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment;\n16. The trial participant is capable and willing to comply with the scheduled visits, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe heart disease;\n3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune disease or inflammatory disease;\n5. Diagnosis of active malignancy within 3 years prior to study randomization;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension inadequately controlled by two antihypertensive agents;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;\n10. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;\n11. Active central nervous system metastases;\n12. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M09D1;\n13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n15. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n16. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n17. Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose;\n18. Clinically significant bleeding or marked bleeding tendency within 4 weeks prior to the first study drug administration;\n19. Inflammatory bowel disease requiring symptomatic or drug intervention, or partial\u002Fcomplete intestinal obstruction within 4 weeks prior to the first study drug administration;\n20. Known psychiatric disorders that may affect compliance with the trial;\n21. Planned vaccination or administration of live vaccine within 28 days prior to the first dose;\n22. Pregnant or breastfeeding women;\n23. Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical trial.","FEMALE",{"count":95,"type":22},126,[26],"This study is a single-arm, open-label, multicenter, non-randomized phase II clinical study evaluating the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic gynecological malignancies and other solid tumors.",[99,30],"Gynecological Malignancies","2026-08-12",{"date":79,"type":35},{"date":103,"type":22},"2026-08",{"date":39,"type":22},{"name":41,"class":42},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":123,"locationsCount":124},"100651677","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-head-and-neck-tumors-and-other-solid-tumors-100651677","NCT07763639","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Head and Neck Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Head and Neck Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Life expectancy ≥3 months;\n5. Locally advanced or metastatic head and neck tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within 2 years;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the protocol requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and they must not be lactating. All enrolled patients (regardless of gender) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;\n15. Participants must be capable of and willing to comply with the study visits, treatment plans, laboratory tests, and other study-related procedures as specified in the protocol.\n\nExclusion Criteria:\n\n1. Received chemotherapy, biotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;\n2. Received immunosuppressive medications within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. History of ≥ Grade 3 toxicity related to anti-angiogenic therapy when previously receiving such treatment;\n7. Diagnosis of another solid malignancy within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Uncontrolled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;\n13. Active central nervous system (CNS) metastases;\n14. History of allergy to recombinant humanized or human-mouse chimeric antibodies, or allergy to any excipient of SI-B036;\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug;\n18. Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of study drug;\n19. Imaging findings indicate that the tumor has invaded or encased the great thoracic vessels, pericardium, or heart;\n20. Clinically significant hemorrhage or obvious bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or lactating women;\n24. Any other conditions that, in the investigator's judgment, make the participant unsuitable for enrollment in this clinical trial.",{"count":52,"type":22},[25],"This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 Bispecific Antibody Injection in patients with locally advanced or metastatic head and neck tumors and other solid tumors.",[117,30],"Head and Neck Tumors","2026-08-10",{"date":120,"type":35},"2026-08-13",{"date":103,"type":22},{"date":39,"type":22},{"name":41,"class":42},2,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":141,"locationsCount":43},"100651660","phase-1-a-study-of-bl-arc002-in-patients-with-locally-advanced-or-metastatic-gastrointestinal-tumors-and-other-solid-tumors-100651660","NCT07763652","A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-ARC002 Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);\n4. Expected survival ≥3 months;\n5. Locally advanced or metastatic esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, or other solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions obtained within 2 years;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the protocol-specified requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days prior to the start of treatment, with a negative serum pregnancy test result, and they must be non-lactating; all study participants (both male and female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the completion of treatment.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe cardiac disease;\n3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of another malignant tumor within 5 years prior to the first dose;\n6. Hypertension inadequately controlled by two antihypertensive agents;\n7. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of Grade ≥2;\n8. Active central nervous system (CNS) metastases;\n9. Subjects with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002;\n10. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n11. Cumulative anthracycline dose \\> 360 mg\u002Fm² from prior (neo)adjuvant anthracycline-based therapy;\n12. Positive for human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n13. Active infection requiring systemic therapy;\n14. Participation in another clinical trial within 4 weeks prior to the first dose;\n15. Pregnant or breastfeeding women;\n16. Subjects with claustrophobia or inability to lie flat for the duration of required examinations due to various reasons;\n17. Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.",{"count":133,"type":22},22,[25],"This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-ARC002 Injection in patients with locally advanced or metastatic solid tumors.",[137,30],"Gastrointestinal Tumors",{"date":120,"type":35},{"date":103,"type":22},{"date":39,"type":22},{"name":41,"class":42},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":159,"leadSponsor":160,"locationsCount":43},"100650766","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-breast-cancer-and-other-solid-tumors-100650766","NCT07753226","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic breast cancer and other solid tumors;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n9. Toxicity from prior antitumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the required criteria;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must be non-lactating; all enrolled patients (both males and females) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;\n15. The trial participant must be able and willing to comply with the protocol-specified visits, treatment plan, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive drug therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior experience of ≥ Grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Poorly controlled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;\n13. Active central nervous system metastases;\n14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036;\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug;\n18. Presence of pleural, abdominal, or pelvic effusion, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of the study drug;\n19. Imaging findings suggesting tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;\n20. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or breastfeeding women;\n24. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.",{"count":150,"type":22},39,[25],"This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic breast cancer and other solid tumors.",[74,154],"Solid Tumor","2026-08-04",{"date":157,"type":35},"2026-08-07",{"date":103,"type":22},{"date":39,"type":22},{"name":41,"class":42},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":177,"leadSponsor":178,"locationsCount":43},"100650231","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-urological-tumors-and-other-solid-tumors-100650231","NCT07744243","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥ 18 years and ≤ 75 years;\n4. Expected survival time ≥ 3 months;\n5. Locally advanced or metastatic urological tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens collected within 2 years from the primary or metastatic lesion, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;\n11. Organ function levels must meet the specified requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤ 1.5, and activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN);\n13. Urine protein ≤ 1+ or ≤ 1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and they must not be breastfeeding; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the completion of treatment;\n15. The trial participant must be willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures as specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior history of ≥ Grade 3 toxicity related to anti-angiogenic therapy when receiving such treatment previously;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Uncontrolled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;\n13. Active central nervous system (CNS) metastases;\n14. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of SI-B036;\n15. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n16. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug;\n18. Presence of pleural, abdominal, or pelvic effusion, or pericardial effusion requiring drainage and\u002For associated with symptoms within 4 weeks prior to the first dose of the study drug;\n19. Imaging findings indicating that the tumor has invaded or encased the great thoracic vessels, pericardium, or heart;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or lactating women;\n24. Other conditions that, in the investigator's opinion, make the subject unsuitable for participation in this clinical trial.",{"count":52,"type":22},[25],"This study is an open-label, multicenter, dose-escalation and dose-expansion, non-randomized phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic urological tumors and other solid tumors.",[172,173],"Urological Cancer","Solid Cancer",{"date":175,"type":35},"2026-08-06",{"date":103,"type":22},{"date":39,"type":22},{"name":41,"class":42},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":124},"100641927","phase-2-a-study-of-bl-b01d1-in-combination-with-osimertinib-as-perioperative-therapy-in-patients-with-egfr-mutated-resectable-non-small-cell-lung-cancerpanku-lung09-100641927","NCT07642024","A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)","A Phase II\u002FIII Randomized Controlled Clinical Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)","Inclusion Criteria:\n\n1. Voluntarily sign informed consent and agree to comply with the protocol requirements;\n2. Aged ≥18 years and ≤75 years, regardless of gender;\n3. Expected survival time ≥3 months;\n4. Patients with non-small cell lung cancer;\n5. One of the EGFR sensitive mutation types detected in the tumor tissue;\n6. Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples;\n7. Undergo pulmonary function testing within 28 days prior to the first dose;\n8. ECOG performance status score of 0 or 1;\n9. No severe cardiac dysfunction;\n10. Organ function levels must meet the required criteria;\n11. Urine protein ≤1+ or \\\u003C1000 mg\u002F24h;\n12. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be lactating; all enrolled trial participants must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;\n2. Trial participants who subsequently receive only segmentectomy or wedge resection;\n3. Trial participants deemed surgically inoperable by the study center's surgical evaluation;\n4. Undergoing major surgery within 4 weeks prior to the first dose, among others;\n5. Previous receipt of systemic anti-tumor therapy for non-small cell lung cancer other than that for this study, among others;\n6. Receiving long-term systemic corticosteroid therapy with prednisone \\>10 mg\u002Fday within 2 weeks prior to randomization, among others;\n7. History of severe heart disease or cerebrovascular disease;\n8. Prolonged QTc interval, complete left bundle branch block, etc.;\n9. Any thrombotic event within 6 months prior to screening;\n10. Trial participants with known or suspected interstitial lung disease, among others;\n11. Diagnosis of active malignant tumors within 5 years prior to study randomization;\n12. Hypertension inadequately controlled by two antihypertensive medications;\n13. Trial participants with poorly controlled blood glucose;\n14. Severe infection occurring within 4 weeks prior to study randomization, among others;\n15. Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;\n16. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;\n17. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;\n18. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n19. Inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, etc.;\n20. History of allergy to the investigational drug, etc.;\n21. History of solid organ transplantation, autologous or allogeneic stem cell transplantation;\n22. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;\n23. History of severe neurological or psychiatric disorders;\n24. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;\n25. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.",{"count":187,"type":22},90,[26,189],"PHASE3","This trial is a registrational Phase II\u002FIII, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.",[192],"Non-small Cell Lung Cancer","2026-07-30",{"date":195,"type":35},"2026-08-03",{"date":197,"type":35},"2026-07-24",{"date":199,"type":22},"2032-12",{"name":41,"class":42},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":218,"leadSponsor":220,"locationsCount":124},"100649816","phase-2-a-study-evaluating-bl-b01d1-in-combination-with-a-pd-1vegf-bispecific-antibody-versus-tislelizumab-plus-platinum-doublet-chemotherapy-as-first-line-treatment-for-locally-advanced-or-metastatic-non-squamous-non-small-cell-lung-cancerpanku-lung06-100649816","NCT07739186","A Study Evaluating BL-B01D1 in Combination With a PD-1\u002FVEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer(PANKU-Lung06)","A Randomized, Open-label, Multicenter Phase II\u002FIII Clinical Study Evaluating BL-B01D1 in Combination With a PD-1\u002FVEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer(PANKU-Lung06)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age ≥ 18 years;\n3. Expected survival time ≥ 3 months;\n4. Patients with locally advanced non-squamous non-small cell lung cancer;\n5. Agree to provide tumor tissue samples obtained at or after diagnosis of locally advanced or metastatic cancer;\n6. Must have at least one measurable lesion as defined by RECIST v1.1;\n7. ECOG performance status score of 0 or 1;\n8. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\n10. Organ function levels must meet the required criteria;\n11. Urinary protein ≤ 2+ or \\\u003C 1000 mg\u002F24h;\n12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must rule out pregnancy; patients must be non-lactating and must use highly effective contraceptive measures throughout the treatment period and for 7 months after the last dose. For male participants whose partners are women of childbearing potential, adequate barrier contraceptive measures must be used throughout the treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Presence of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma components, or squamous carcinoma components exceeding 10%;\n2. Evidence suggesting the presence of EGFR-sensitive mutations, etc.;\n3. Patients who have received prior systemic therapy;\n4. Prior receipt of therapies targeting the mechanism of tumor immunity;\n5. Prior receipt of antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, etc.;\n6. Trial participants who have received prior systemic anti-angiogenic therapy;\n7. Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization;\n8. History of severe cardiac or cerebrovascular disease;\n9. Receiving long-term systemic corticosteroid therapy (e.g., \\>10 mg\u002Fday prednisone) prior to the first dose;\n10. Active autoimmune diseases and inflammatory diseases;\n11. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n12. Prolonged QT interval, complete left bundle branch block, etc.;\n13. Diagnosis of active malignancy within 3 years before study randomization;\n14. Hypertension poorly controlled by two antihypertensive medications;\n15. Patients with poorly controlled blood glucose;\n16. History of ILD requiring steroid therapy, current ILD, or ≥ grade 2 radiation pneumonitis, etc.;\n17. Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;\n18. Patients with active central nervous system metastases;\n19. Occurrence of severe infection within 4 weeks before study randomization;\n20. Presence of large serous cavity effusions, or symptomatic serous cavity effusions, etc.;\n21. Imaging findings suggesting tumor invasion or encasement of abdominal, thoracic, or other regions;\n22. Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;\n23. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;\n24. Patients with a history of inflammatory bowel disease, extensive bowel resection, immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.;\n25. History of allergy to recombinant humanized antibodies or allergy to the investigational drug, etc.;\n26. History of autologous or allogeneic stem cell transplantation;\n27. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;\n28. History of severe neurological or psychiatric disorders;\n29. Receipt of other unapproved investigational drugs or treatments within 4 weeks before study randomization;\n30. Trial participants who plan to receive or have received live vaccines within 28 days before study randomization;\n31. Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial due to complications or other circumstances.",{"count":209,"type":22},120,[26,189],"This trial is a registrational randomized, open-label, multicenter Phase II\u002FIII study designed to evaluate the efficacy and safety of BL-B01D1 in combination with a PD-1\u002FVEGF bispecific antibody in patients with locally advanced or metastatic non-squamous non-small cell lung cancer.",[213],"Non-squamous Non-small Cell Lung Cancer","2026-07-28",{"date":216,"type":35},"2026-07-31",{"date":103,"type":22},{"date":219,"type":22},"2029-12",{"name":41,"class":42},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":237,"locationsCount":124},"100649784","phase-2-a-study-comparing-bl-b01d1-in-combination-with-pd-1vegf-bispecific-antibody-versus-chemotherapy-in-combination-with-pd-1vegf-bispecific-antibody-in-first-line-patients-with-locally-advanced-or-metastatic-squamous-non-small-cell-lung-cancerpanku-lung05-100649784","NCT07739199","A Study Comparing BL-B01D1 in Combination With PD-1\u002FVEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1\u002FVEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)","A Phase II\u002FIII Clinical Study Comparing BL-B01D1 in Combination With PD-1\u002FVEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1\u002FVEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age ≥18 years;\n3. Expected survival time ≥3 months;\n4. Patients with locally advanced or metastatic squamous non-small cell lung cancer;\n5. Agree to provide tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic disease;\n6. Must have at least one measurable lesion as defined by RECIST v1.1;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n10. Organ function levels must meet the specified requirements;\n11. Urinary protein ≤1+ or \\\u003C1000 mg\u002F24h;\n12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test excluding pregnancy, and patients must be non-lactating; all enrolled patients (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Prior histological or cytological evidence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;\n2. Indications of the presence of EGFR-sensitive mutations, among others;\n3. Patients who have received prior systemic therapy;\n4. Prior treatment with agents targeting the mechanism of tumor immune action;\n5. Prior treatment with ADC drugs that use topoisomerase I inhibitors as the toxin, among others;\n6. Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization;\n7. History of severe heart disease or cerebrovascular disease;\n8. Receipt of long-term systemic corticosteroid therapy (e.g., prednisone \\>10 mg\u002Fday) before the first dose;\n9. Active autoimmune diseases and inflammatory diseases requiring systemic treatment within 2 years;\n10. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n11. Prolonged QTc interval, complete left bundle branch block, among others;\n12. Diagnosis of active malignancy within 3 years before study randomization;\n13. Hypertension inadequately controlled by two antihypertensive medications;\n14. Patients with poorly controlled blood glucose levels;\n15. History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, among others;\n16. Pulmonary diseases leading to clinically severe impairment of respiratory function;\n17. Patients with active central nervous system metastases;\n18. Severe infection occurring within 4 weeks before study randomization;\n19. Presence of large serous cavity effusions or symptomatic serous cavity effusions, among others;\n20. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;\n21. Severe non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;\n22. Trial participants with clinically significant bleeding or a significant bleeding tendency within 4 weeks prior to signing informed consent;\n23. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune enteritis, intestinal obstruction, or chronic diarrhea, among others;\n24. History of allergy to recombinant humanized antibodies or hypersensitivity to any excipient of BL-B01D1;\n25. History of autologous or allogeneic stem cell transplantation;\n26. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;\n27. History of severe neurological or psychiatric disorders;\n28. Receipt of other unapproved clinical study drugs or treatments within 4 weeks before study randomization;\n29. Trial participants planning to receive or having received live vaccines within 28 days before study randomization;\n30. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.",{"count":229,"type":22},200,[26,189],"This trial is a registrational Phase II\u002FIII randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in combination with PD-1\u002FVEGF bispecific antibody in first-line patients with locally advanced or metastatic squamous non-small cell lung cancer.",[233],"Squamous Non-small-cell Lung Cancer",{"date":216,"type":35},{"date":103,"type":22},{"date":219,"type":22},{"name":41,"class":42},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":254,"leadSponsor":255,"locationsCount":124},"100649183","phase-3-a-study-comparing-bl-m07d1-with-physicians-choice-therapy-in-patients-with-her2-ihc3-advanced-colorectal-cancer-who-failed-prior-treatment-with-oxaliplatin-fluorouracil-and-irinotecan-100649183","NCT07730489","A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan","A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Participants must be ≥18 years and ≤75 years of age on the day of signing the informed consent form;\n3. Expected survival time ≥3 months;\n4. Patients with histologically or cytologically confirmed metastatic colorectal cancer;\n5. Prior failure of standard therapy;\n6. Patients suitable for receiving the control regimen treatment;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. Organ function levels must meet the requirements;\n11. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must exclude pregnancy; they must be non-lactating; all enrolled participants must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Have undergone surgical treatment, radical radiotherapy, chemotherapy, immunotherapy, etc. within 4 weeks before the first dose;\n2. Have previously received ADC drug therapy using camptothecin derivatives as toxins, or have previously received HER2-ADC drug therapy;\n3. History of severe cardiovascular or cerebrovascular disease within half a year before screening;\n4. Concurrent pulmonary disease resulting in severely impaired lung function;\n5. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n6. Diagnosed with active malignancy within 3 years before study randomization;\n7. Any thrombotic event within 6 months before randomization;\n8. Hypertension inadequately controlled by two antihypertensive agents;\n9. Poorly controlled blood glucose;\n10. History of interstitial lung disease (ILD)\u002Finterstitial pneumonia, current ILD\u002Finterstitial pneumonia, etc.;\n11. Trial participants with active central nervous system metastases;\n12. Patients with a history of allergy to recombinant humanized antibodies or allergy to any excipient of BL-M07D1;\n13. History of autologous or allogeneic stem cell transplantation or organ transplantation;\n14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;\n15. Severe infection occurring within 4 weeks before the first use of the study drug;\n16. Patients with massive serous cavity effusion, or symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;\n17. Receiving long-term systemic corticosteroid therapy at a dose \\>10 mg\u002Fday prednisone within 14 days before randomization, etc.;\n18. History of severe neurological or psychiatric disease;\n19. Severe and non-healing wounds, ulcers, or fractures occurring within 4 weeks before signing informed consent;\n20. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;\n21. Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;\n22. Received other unapproved clinical study drugs or treatments within 4 weeks before study randomization;\n23. Patients planning to receive or having received live vaccines within 28 days before the first dose;\n24. Imaging findings indicate that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, or pharynx;\n25. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance, etc., that may increase the risk of participating in the study, interfere with the study results, or are considered by the investigator as unsuitable for participation in this study.",{"count":246,"type":22},130,[189],"This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with advanced colorectal cancer who have HER2 IHC3+ and have failed prior treatment with oxaliplatin, fluorouracil and irinotecan.",[250],"Colorectal Cancer","2026-07-23",{"date":214,"type":35},{"date":103,"type":22},{"date":83,"type":22},{"name":41,"class":42},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":273,"locationsCount":124},"100641255","phase-3-a-study-of-bl-m07d1-versus-physicians-choice-of-chemotherapy-in-patients-with-her2-expressing-locally-advanced-or-metastatic-biliary-tract-cancer-after-platinum-containing-chemotherapy-failure-100641255","NCT07606599","A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure","A Phase III Randomized Controlled Clinical Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Be ≥18 years and ≤75 years old on the day the trial participant signs the informed consent form;\n3. Have an expected survival time of ≥3 months;\n4. Have a histologically or cytologically confirmed pathological diagnosis of biliary tract cancer;\n5. Have locally advanced or metastatic biliary tract cancer;\n6. Have a known genetic mutation;\n7. Be suitable to receive the control arm regimen;\n8. Have at least one measurable lesion as defined by RECIST v1.1;\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n10. Have recovered from previous anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n11. Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;\n12. Meet the required organ function levels;\n13. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative for pregnancy; they must be non-lactating. All enrolled trial participants should practice adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Received surgical treatment, radical radiotherapy, chemotherapy, etc., within 4 weeks prior to the first dose;\n2. Patients with locally advanced or metastatic biliary tract cancer who are suitable for receiving curative-intent local therapy;\n3. Previously treated with ADC drugs using camptothecin derivatives as the toxin;\n4. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;\n5. Concomitant pulmonary disease resulting in severely impaired lung function;\n6. Prolonged QTc interval, complete left bundle branch block, etc.;\n7. Diagnosed with active malignant tumors within 3 years prior to study randomization;\n8. Hypertension inadequately controlled by two antihypertensive medications;\n9. Patients with poorly controlled blood glucose levels;\n10. History of interstitial lung disease (ILD) \u002F interstitial pneumonia, etc.;\n11. Patients with active central nervous system (CNS) metastases;\n12. Patients with a history of allergy to recombinant humanized antibodies or any excipient of BL-M07D1;\n13. History of autologous or allogeneic stem cell transplantation;\n14. Positive for human immunodeficiency virus (HIV) antibodies, active Hepatitis B virus infection, or active Hepatitis C virus infection;\n15. Occurrence of severe infection, etc., within 4 weeks prior to the first dose of the study drug;\n16. Patients with a prior history of severe biliary tract infection\u002Fbleeding and biliary fistula;\n17. Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.;\n18. Receiving long-term systemic corticosteroid therapy (e.g., \\>10 mg\u002Fday of prednisone or equivalent) prior to randomization;\n19. History of severe neurological or psychiatric disorders;\n20. Occurrence of serious and non-healing wounds, ulcers, or bone fractures within 4 weeks prior to signing informed consent;\n21. Patients with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n22. Intestinal obstruction, Crohn's disease, ulcerative colitis, chronic diarrhea, etc.;\n23. Received other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;\n24. Patients who plan to receive or have received a live vaccine within 28 days prior to the first dose;\n25. Imaging findings indicate that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, or pharynx;\n26. Presence of other serious physical conditions, laboratory abnormalities, or poor compliance, etc., that may increase the risk of participating in the study, interfere with the study results, or make the patient unsuitable for participation in the study as judged by the investigator.",{"count":264,"type":22},398,[189],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after platinum-containing chemotherapy failure.",[268],"Biliary Tract Cancer",{"date":197,"type":35},{"date":271,"type":35},"2026-07-07",{"date":39,"type":22},{"name":41,"class":42},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":43},"100637627","phase-3-a-study-comparing-bl-b01d1-with-treatment-of-physicians-choice-in-patients-with-locally-advanced-or-metastatic-biliary-tract-cancer-after-failure-of-platinum-based-chemotherapypanku-btc01-100637627","NCT07582315","A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. No gender restriction, aged ≥18 years and ≤75 years;\n3. Expected survival time ≥3 months;\n4. Patients with locally advanced or metastatic biliary tract cancer;\n5. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;\n6. Must have at least one measurable lesion as defined by RECIST v1.1;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n10. Organ function levels must meet the specified requirements;\n11. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n12. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy testing excluding pregnancy, and they must be non-lactating; all enrolled patients (regardless of male or female) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to randomization;\n2. Patients with locally advanced or metastatic biliary tract cancer who are suitable for curative local therapy;\n3. Prior use of ADC drugs using topoisomerase I inhibitors as the toxin, or prior treatment with ADC drugs targeting EGFR and\u002For HER3;\n4. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n6. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n7. Diagnosis of active malignancy within 3 years prior to randomization;\n8. Hypertension poorly controlled by two antihypertensive medications, history of hypertensive crisis or hypertensive encephalopathy;\n9. Poorly controlled blood glucose levels;\n10. History of non-infectious interstitial lung disease (ILD) treated with steroids, etc.;\n11. Concurrent pulmonary disease resulting in clinically severe respiratory impairment;\n12. Patients with active central nervous system metastases;\n13. Severe infection occurring within 4 weeks prior to randomization;\n14. Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions;\n15. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, thorax, neck, or pharynx;\n16. Serious non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed consent form;\n17. Clinically significant bleeding or obvious bleeding tendencies in trial participants within 4 weeks prior to signing the informed consent form;\n18. Patients with a history of allergy to recombinant humanized antibodies or to any excipient component of BL-B01D1;\n19. Positive for human immunodeficiency virus antibodies, active tuberculosis, active hepatitis B virus infection, or hepatitis C virus infection;\n20. History of severe neurological or psychiatric disorders;\n21. Trial participants planning to receive or having received a live vaccine within 28 days prior to randomization;\n22. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":282,"type":22},538,[189],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.",[268],{"date":197,"type":35},{"date":288,"type":35},"2026-06-29",{"date":39,"type":22},{"name":41,"class":42},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":309,"locationsCount":124},"100631562","phase-3-a-study-comparing-bl-b01d1-combined-with-tislelizumab-versus-platinum-containing-chemotherapy-combined-with-tislelizumab-as-first-line-treatment-in-patients-with-extensive-stage-small-cell-lung-cancerpanku-lung07-100631562","NCT07502300","A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 for Injection Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age ≥ 18 years;\n3. Expected survival time ≥ 3 months;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. Patients with histopathologically and\u002For cytologically confirmed extensive-stage small cell lung cancer;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesions within 3 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\n10. Organ function levels must meet the requirements;\n11. Urinary protein ≤ 2+ or \\\u003C 1000 mg\u002F24h;\n12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must be negative; patients must not be breastfeeding. All enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Pathology indicates small cell carcinoma containing non-small cell carcinoma components;\n2. Patients who have previously received systemic treatment;\n3. Previous treatment with ADC drugs where the small molecule toxin is a topoisomerase I inhibitor;\n4. Use of immunomodulatory drugs within 14 days prior to the first dose of the study drug;\n5. History of severe heart disease or cerebrovascular disease;\n6. Receiving long-term systemic corticosteroid therapy at a dose \\>10 mg\u002Fday of prednisone or equivalent prior to the first dose;\n7. Active autoimmune diseases and inflammatory diseases;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n9. Prolonged QT interval, complete left bundle branch block, etc.;\n10. Diagnosis of active malignancy within 3 years prior to study randomization;\n11. Hypertension inadequately controlled with two antihypertensive medications;\n12. Poorly controlled diabetes mellitus;\n13. History of interstitial lung disease (ILD)\u002Fpneumonitis requiring steroid therapy, etc.;\n14. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;\n15. Patients with active central nervous system (CNS) metastases;\n16. Severe infection within 4 weeks prior to study randomization;\n17. Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.;\n18. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;\n19. Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n21. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea;\n22. History of allergy to recombinant humanized antibodies or any excipient component of BL-B01D1;\n23. History of autologous or allogeneic stem cell transplantation;\n24. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;\n25. History of severe neurological or psychiatric disorders;\n26. Receipt of other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;\n27. Subjects planning to receive or having received live vaccines within 28 days prior to study randomization;\n28. Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial due to complications or other circumstances.",{"count":299,"type":22},562,[189],"This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients with extensive-stage small cell lung cancer.",[303],"Extensive-stage Small-cell Lung Cancer",{"date":305,"type":35},"2026-07-27",{"date":307,"type":35},"2026-06-15",{"date":219,"type":22},{"name":41,"class":42},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":93,"minAge":18,"maxAge":19,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":327,"locationsCount":43},"100649137","phase-3-a-study-of-bl-b01d1-plus-an-anti-pd-1-antibody-versus-nab-paclitaxel-plus-an-anti-pd-1-antibody-in-patients-with-previously-untreated-locally-advanced-inoperable-or-metastatic-triple-negative-breast-cancer-whose-tumors-express-pd-l1-panku-breast04-100649137","NCT07729956","A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)","A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. Female patients aged 18 to 75 years;\n3. Expected survival time ≥ 3 months;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. Pathologically confirmed recurrent or metastatic triple-negative breast cancer;\n6. Confirmed PD-L1 expression positivity by central laboratory testing;\n7. No prior systemic anti-tumor therapy in the advanced\u002Frecurrent or metastatic setting;\n8. Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;\n9. Must have at least one measurable lesion as defined by RECIST v1.1;\n10. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;\n12. Organ function levels must meet the protocol-specified requirements;\n13. Urine protein ≤ 1+ or \\\u003C 1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test (serum) must be performed within 7 days before starting treatment, and pregnancy must be ruled out; patients must not be lactating. All enrolled patients (regardless of sex) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;\n2. Prior exposure to ADC drugs with topoisomerase I inhibitor payload;\n3. Prior treatment with other T-cell receptor-targeting agents (excluding PD-1\u002FPD-L1);\n4. Use of immunomodulators within 14 days before the first study drug dose;\n5. History of severe cardiac or cerebrovascular disease;\n6. Receiving chronic systemic corticosteroids at \\>10 mg\u002Fday prednisone before the first dose;\n7. Active autoimmune or inflammatory disease;\n8. Any thrombotic event within 6 months before randomization;\n9. Prolonged QTc, complete left bundle branch block, or similar;\n10. Active malignancy diagnosed within 3 years before randomization;\n11. Hypertension uncontrolled by two antihypertensives;\n12. Poorly controlled diabetes\u002Fhyperglycemia;\n13. History of steroid-treated ILD\u002Finterstitial pneumonitis;\n14. Concurrent lung disease causing clinically significant respiratory impairment;\n15. Active CNS metastases;\n16. Severe infection within 4 weeks before randomization;\n17. Massive or symptomatic serosal effusion;\n18. Severe non-healing wound, ulcer, or fracture within 4 weeks before consent;\n19. Clinically significant bleeding or bleeding tendency within 4 weeks before consent;\n20. Inflammatory bowel disease, extensive bowel resection, immune enteritis, bowel obstruction, or chronic diarrhea;\n21. Allergy or contraindication to the study drug;\n22. History of autologous\u002Fallogeneic stem cell transplantation;\n23. HIV antibody positive, active HBV, or active HCV;\n24. History of severe neurological or psychiatric illness;\n25. Received or planning to receive live vaccine within 28 days before randomization;\n26. Other conditions rendering the patient unsuitable per investigator's judgment.",{"count":318,"type":22},436,[189],"This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.",[322],"Triple-Negative Breast Cancer (TNBC)","2026-07-22",{"date":214,"type":35},{"date":103,"type":22},{"date":219,"type":22},{"name":41,"class":42},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":343,"leadSponsor":344,"locationsCount":124},"100643113","phase-2-a-study-of-bl-b01d1-combination-therapy-in-patients-with-metastatic-castration-resistant-prostate-cancer-100643113","NCT07641855","A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer","A Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Age ≥ 18 years;\n3. Expected survival time ≥ 3 months;\n4. Unresectable metastatic castration-resistant prostate cancer;\n5. Meet the definition of mCRPC according to PCWG3 criteria;\n6. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 3 years or fresh tissue samples;\n7. Meet the evaluable lesion requirement defined by any one of the following assessment criteria;\n8. ECOG performance status score of 0 or 1;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\n11. Organ function levels must meet the required criteria;\n12. Urine protein ≤ 1+ or \\\u003C 1000 mg\u002F24h;\n13. All enrolled patients must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Patients with metastatic castration-resistant prostate cancer who are suitable for radical local therapy;\n2. Patients with non-prostatic acinar adenocarcinoma confirmed by histopathology or cytology, among others;\n3. Patients who have previously received antibody-drug conjugates using topoisomerase I inhibitors as the toxin, among others;\n4. Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to study randomization;\n5. History of severe heart disease or cerebrovascular disease;\n6. Long-term systemic corticosteroid therapy with prednisone \\>10 mg\u002Fday ongoing before the first dose, among others;\n7. Active autoimmune diseases and inflammatory diseases;\n8. Any thrombotic event within 6 months prior to randomization;\n9. Prolonged QTc interval, complete left bundle branch block, etc.;\n10. Diagnosis of active malignant tumors within 3 years prior to study randomization;\n11. Hypertension inadequately controlled by two antihypertensive medications;\n12. Patients with poorly controlled blood glucose;\n13. History of ILD requiring steroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;\n14. Concurrent pulmonary diseases resulting in clinically severe respiratory function impairment;\n15. Patients with active central nervous system metastases;\n16. Severe infection occurring within 4 weeks prior to study randomization, etc.;\n17. Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;\n18. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;\n19. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;\n20. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n21. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea, etc.;\n22. Patients with a history of allergy to recombinant humanized antibodies or allergy to the investigational drug;\n23. History of autologous or allogeneic stem cell transplantation;\n24. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;\n25. History of severe neurological or psychiatric disorders;\n26. Receipt of other unapproved clinical investigational drugs or treatments within 4 weeks prior to study randomization;\n27. Trial participants planning to receive vaccination or having received live vaccines within 28 days prior to study randomization;\n28. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.",{"count":336,"type":22},180,[26,189],"This study will first conduct a phase II clinical study, and on the basis of the phase II clinical study, subsequent clinical research will be carried out.",[340],"Castration-resistant Prostate Cancer",{"date":251,"type":35},{"date":37,"type":22},{"date":39,"type":22},{"name":41,"class":42},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":362,"locationsCount":43},"100552608","phase-2-a-study-of-bl-b01d1pd-1-monoclonal-antibody-in-patients-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-nasopharyngeal-carcinoma-and-other-solid-tumors-100552608","NCT06475300","A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Any gender;\n3. Age: ≥18 years old;\n4. Expected survival time for 3 months or more;\n5. Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and\u002For cytology;\n6. Subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. ECOG 0 or 1;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. No serious cardiac dysfunction, left ventricular ejection fraction 50% or higher;\n11. screening period not allowed within 14 days before a blood transfusion, are not allowed to use any cell growth factor, and\u002For liters of platelet medicine, organ function level must conform to the requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;\n13. The urine protein + 2 or 1000 mg \u002F 24 h or less or less;\n14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy;\n2. In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;\n3. Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Fluorouracil class oral drugs, etc.;\n4. Serious heart disease;\n5. Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia;\n6. Active autoimmune and inflammatory diseases;\n7. Before the first delivery within 5 years diagnosed as other malignant tumor;\n8. Two antihypertensive drugs poorly controlled hypertension;\n9. Patients with poor glycemic control;\n10. With a history of ILD, current ILD or suspected suffering from such diseases during screening;\n11. Complicated with pulmonary diseases leading to severe respiratory function impairment;\n12. There is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients;\n13. Imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels;\n14. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;\n15. Active central nervous system of patients;\n16. For restructuring or human mouse chimeric antibody on study of humanized anti-platelet antibody has a history of allergies or allergic to BL - B01D1 any supplementary material composition of patients;\n17. Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);\n18. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;\n19. Active infection requiring systemic therapy;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n21. Had participated in another clinical trial within 4 weeks before the first dose;\n22. Other conditions for trial participation were not considered appropriate by the investigator.",{"count":353,"type":22},570,[26],"This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.",[192,357,154],"Nasopharyngeal Carcinoma",{"date":251,"type":35},{"date":360,"type":35},"2024-06-25",{"date":39,"type":22},{"name":41,"class":42},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":43},"100552293","phase-2-a-study-of-bl-b01d1pd-1-monoclonal-antibody-in-patients-with-unresectable-locally-advanced-or-recurrent-metastatic-triple-negative-breast-cancer-100552293","NCT06471205","A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent and follow the requirements of the protocol;\n2. Age: ≥18 years old and ≤75 years old;\n3. Expected survival time ≥3 months;\n4. ECOG 0 or 1;\n5. Subjects with histologically and\u002For cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer;\n6. Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer;\n7. A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided;\n8. Must have at least one place in accordance with RECIST v1.1 define measurable lesions;\n9. No blood transfusion, no use of cell growth factors and\u002For platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements;\n10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;\n11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;\n2. Palliative radiotherapy within 2 weeks before the first dose;\n3. Patients with checkpoint inhibitors prior to neoadjuvant\u002Fadjuvant chemotherapy;\n4. Use of an immunomodulatory drug within 14 days before the first dose of study drug;\n5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;\n6. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n7. Active autoimmune and inflammatory diseases;\n8. Receiving long-term systemic corticosteroid therapy, etc., before the first dose;\n9. Other malignant tumors that progressed or required treatment within 5 years before the first dose;\n10. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;\n11. Present grade ≥2 radiation pneumonitis according to the RTOG\u002FEORTC definition; Patients with current ILD;\n12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment;\n13. 6 months prior to screening needs treatment intervention unstable thrombotic events;\n14. Patients with active central nervous system metastases;\n15. Patients with massive or symptomatic effusions or poorly controlled effusions;\n16. Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug;\n17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n19. Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks;\n20. Participated in another clinical trial within 4 weeks before the first dose;\n21. Patients with superior vena cava syndrome should not be rehydrated;\n22. Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness;\n23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;\n24. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;\n25. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;\n27. Other circumstances considered by the investigator to be inappropriate for participation in the trial.",{"count":371,"type":22},52,[26],"This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.",[375],"Triple-negative Breast Cancer",{"date":251,"type":35},{"date":378,"type":35},"2024-08-02",{"date":380,"type":22},"2028-06",{"name":41,"class":42},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":389,"targetDuration":4,"studyType":23,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":399,"locationsCount":43},"100549706","phase-2-a-study-of-bl-b01d1pd-1-monoclonal-antibody-in-patients-with-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-and-other-solid-tumors-100549706","NCT06437522","A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors","A Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors","Inclusion Criteria:\n\n1. Subject volunteered to participate in the study and signed an informed consent;\n2. Male or female aged ≥18 years and ≤75 years;\n3. Expected survival time ≥3 months;\n4. ECOG score 0-1;\n5. Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology and\u002For cytology;\n6. Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. No blood transfusion and no use of cell growth factors and\u002For platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Prior treatment with an ADC drug with TOP I inhibitors as a toxin;\n2. Before the first delivery within four weeks or five half-life used anti-tumor treatment; Palliative radiotherapy was given within 2 weeks before the first dose;\n3. Received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma;\n4. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis;\n5. Use of an immunomodulatory drug within 14 days before the first dose of study drug;\n6. Systemic corticosteroids were required within 2 weeks before the first dose of the study;\n7. Has a history of severe disease of heart head blood-vessel;\n8. Active autoimmune and inflammatory diseases;\n9. Other malignant tumors that progressed or required treatment within 3 years before the first dose;\n10. With ILD requiring steroid treatment, current ILD, or suspected ILD at screening;\n11. Presence of: a) poorly controlled diabetes mellitus before study treatment; b) poorly controlled hypertension; c) history of hypertensive crisis or hypertensive encephalopathy;\n12. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n13. Patients with active central nervous system metastasis;\n14. Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage;\n15. Had allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients;\n16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n17. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;\n18. Active infection requiring systemic therapy;\n19. Had participated in another clinical trial within 4 weeks before the first dose;\n20. Who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders;\n21. Other circumstances that the investigator deemed inappropriate for participation in the trial.",{"count":390,"type":22},46,[26],"This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors.",[394],"Head and Neck Squamous Cell Carcinoma",{"date":251,"type":35},{"date":397,"type":35},"2024-06-07",{"date":380,"type":22},{"name":41,"class":42},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":416,"locationsCount":43},"100549705","phase-2-a-study-of-bl-b01d1pd-1-monoclonal-antibody-in-patients-with-extensive-stage-small-cell-lung-cancer-100549705","NCT06437509","A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer","A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Subject volunteered to participate in the study and signed an informed consent;\n2. Male or female aged ≥18 years and ≤75 years;\n3. Expected survival time ≥3 months;\n4. ECOG score 0-1;\n5. Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and \u002F or cytology;\n6. A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. No blood transfusion and no use of cell growth factors and\u002For platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors;\n2. Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer;\n3. Pathology suggested small cell carcinoma containing non-small cell carcinoma components;\n4. Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ;\n5. Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ;\n6. QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ;\n7. Active autoimmune diseases and inflammatory diseases ;\n8. Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose;\n9. Other malignancies that have progressed or require treatment within 5 years prior to the first dose;\n10. Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening;\n11. Prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;\n12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; Except for infusion set-related thrombosis;\n13. Concurrent pulmonary disease leading to severe clinical impairment of respiratory function;\n14. Patients with active central nervous system metastases;\n15. Patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions;\n16. History of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug;\n17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n18. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n19. Severe infection within 4 weeks prior to first dose of study drug; Lung infection or active lung inflammation within 4 weeks;\n20. Have participated in another clinical trial within 4 weeks prior to the first dose;\n21. Have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders;\n22. Imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest;\n23. Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy;\n24. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy;\n25. Subjects who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose;\n26. Other conditions that the investigator considers unsuitable to participate in this clinical trial.",{"count":408,"type":22},66,[26],"This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.",[303],{"date":251,"type":35},{"date":414,"type":35},"2024-06-13",{"date":83,"type":22},{"name":41,"class":42},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":43},"100547242","phase-2-a-study-of-bl-b01d1--pd-1-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-100547242","NCT06405425","A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + PD-1 Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma","Inclusion Criteria:\n\n1. All subjects voluntarily participated in the study and signed informed consent;\n2. Male or female aged ≥18 years and ≤75 years;\n3. Expected survival time ≥3 months;\n4. ECOG 0-1;\n5. Unresectable locally advanced or metastatic urothelial carcinoma confirmed by histopathology and\u002For cytology;\n6. Participants should not have received previous systemic therapy for locally advanced or metastatic urothelial cancer;\n7. A biopsy sample of archived tumor tissue or metastatic urothelial carcinoma must be available within 3 years for PD-L1 and other testing;\n8. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n9. The level of organ function must meet the requirements on the premise that blood transfusion and the use of any cell growth factors and\u002For platelet-raising drugs are not allowed within 14 days before the first dose;\n10. Previous treatment-related toxicity returned to ≤ grade 1 defined by NCI-CTCAE v5.0;\n11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Prior ADC recipients with TOPI inhibitors as toxin;\n2. Palliative radiotherapy within 2 weeks before the first dose;\n3. Prior immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis;\n4. Use of an immunomodulatory drug within 14 days before the first dose of study drug;\n5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;\n6. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n7. Active autoimmune and inflammatory diseases;\n8. Receiving \\&gt before the first dose; Long-term systemic corticosteroid therapy with prednisone 10mg\u002Fd;\n9. Other malignant tumors that progressed or required treatment within 5 years before the first dose;\n10. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;\n11. History of ILD, current ILD, or suspected ILD;\n12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment;\n13. Screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months; Infusion-related thrombosis was excluded;\n14. Patients with active central nervous system metastases;\n15. Patients with massive or symptomatic effusions or poorly controlled effusions;\n16. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug;\n17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n19. Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks;\n20. Participated in another clinical trial within 4 weeks before the first dose;\n21. Patients with superior vena cava syndrome should not be rehydrated;\n22. Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness;\n23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;\n24. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;\n25. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;\n27. Other circumstances considered by the investigator to be inappropriate for participation in the trial.",{"count":371,"type":22},[26],"This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 combination therapy in patients with locally advanced or metastatic urothelial carcinoma.",[428],"Urothelial Carcinoma",{"date":251,"type":35},{"date":431,"type":35},"2024-05-29",{"date":380,"type":22},{"name":41,"class":42},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":450,"locationsCount":43},"100524882","phase-1-a-study-of-bl-m07d1-in-patients-with-her2-mutated-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100524882","NCT06114511","A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2 Mutated, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent and follow the requirements of the protocol.\n2. No gender limit.\n3. Age: ≥18 years old and ≤75 years old.\n4. expected survival time ≥3 months.\n5. Histologically or cytologically confirmed, unresectable locally advanced or metastatic non-small cell lung cancer.\n6. Confirmed known HER2-sensitive mutations, investigator-confirmed previous testing results, and trial site laboratory testing results were acceptable.\n7. Patients in the advanced stage who had received platinum-based chemotherapy and immunotherapy concurrent or sequential therapy were unable to tolerate standard treatment or had disease progression during or after treatment.\n8. Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing; Participants who were unable to provide tumor tissue samples could be enrolled if they met other inclusion and exclusion criteria after evaluation by investigators.\n9. Must have at least one measurable lesion according to RECIST v1.1 definition.\n10. ECOG score 0 or 1.\n11. Toxicity of previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 .\n12. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%.\n13. Organ function levels must meet the requirements.\n14. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN.\n15. Urine protein ≤2+ or ≤1000mg\u002F24h.\n16. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, serum\u002Furine pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Received chemotherapy, biological therapy, immunotherapy or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.).\n2. Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin.\n3. Presence of other gene mutations for targeted drug therapy.\n4. A history of severe cardiovascular and cerebrovascular diseases.\n5. Active autoimmune or inflammatory diseases.\n6. Patients with other malignant tumors within 5 years before the first administration.\n7. Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; Infusion-related thrombosis was excluded.\n8. Patients with poorly controlled pericardial effusion, pleural effusion, peritoneal effusion, or pelvic effusion with clinical symptoms were judged by the investigator to be ineligible for enrollment.\n9. Hypertension poorly controlled by antihypertensive drugs (systolic BP \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg).\n10. Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases.\n11. Patients with central nervous system (CNS) metastases and\u002For carcinomatous meningitis (meningeal metastases). .\n12. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1.\n13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).\n14. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \\> lower detection limit) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA \\> lower detection limit).\n15. Active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.\n16. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose).\n17. Pregnant or lactating women.\n18. Other circumstances considered by the investigator to be inappropriate for participation in the trial.",{"count":442,"type":22},98,[25,26],"This phase Ib\u002FII study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of injectable BL-M07D1 in patients with HER2-mutated, locally advanced or metastatic non-small cell lung cancer.",[192],{"date":251,"type":35},{"date":448,"type":35},"2024-04-24",{"date":83,"type":22},{"name":41,"class":42},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":468,"locationsCount":43},"100642838","phase-3-a-study-comparing-bl-b01d1-with-chemotherapy-of-physicians-choice-in-patients-with-unresectable-locally-advanced-recurrent-or-metastatic-hrher2--breast-cancer-after-failure-of-prior-endocrine-therapypanku-breast03-100642838","NCT07648914","A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+\u002FHER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+\u002FHER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age ≥ 18 years;\n4. Expected survival time ≥ 3 months;\n5. Patients with unresectable locally advanced, recurrent, or metastatic HR+ HER2- breast cancer;\n6. Trial participants have not received systemic chemotherapy;\n7. Trial participants have progressed after at least one line of endocrine therapy, etc.;\n8. Documented radiographic disease progression prior to enrollment;\n9. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesion within 3 years;\n10. Must have at least one measurable lesion as defined by RECIST v1.1;\n11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n12. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n13. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;\n14. Must meet required organ function levels;\n15. Urinary protein ≤ 2+ or \\\u003C 1000 mg\u002F24h;\n16. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must not be breastfeeding; all enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.\n\nExclusion Criteria:\n\n1. Previously treated with ADC drugs that use topoisomerase I inhibitors as the toxin or target EGFR and\u002For HER3;\n2. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;\n3. Previous treatment with anthracycline drugs where the equivalent cumulative dose of doxorubicin exceeds 360 mg\u002Fm²;\n4. History of severe cardiovascular or cerebrovascular diseases;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n6. Prolonged QT interval, complete left bundle branch block, etc.;\n7. Diagnosis of another malignancy within 3 years before the first dose;\n8. Hypertension poorly controlled by two antihypertensive medications;\n9. Poorly controlled blood glucose levels;\n10. History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, etc.;\n11. Concurrent pulmonary diseases causing clinically severe respiratory function impairment;\n12. Patients with active central nervous system metastases;\n13. Presence of large serous cavity effusions or symptomatic serous cavity effusions, etc.;\n14. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;\n15. Severe infection within 4 weeks before study randomization;\n16. Severe, unhealed wounds, ulcers, or fractures within 4 weeks before signing the informed consent form;\n17. Trial participants with clinically significant bleeding or a significant bleeding tendency within 4 weeks prior to signing the informed consent form;\n18. History of inflammatory bowel disease, extensive bowel resection, etc.;\n19. Patients with a history of allergy to recombinant humanized antibodies or allergy to BL-B01D1 or any of its excipients;\n20. History of autologous or allogeneic stem cell transplantation;\n21. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;\n22. Receipt of other unapproved clinical study drugs or treatments within 4 weeks before the first dose;\n23. Trial participants planning to receive or having received live vaccines within 28 days before the first dose;\n24. Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial due to complications or other reasons.",{"count":459,"type":22},446,[189],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+\u002FHER2- breast cancer after failure of prior endocrine therapy.",[74],"2026-07-21",{"date":251,"type":35},{"date":466,"type":35},"2026-07-06",{"date":39,"type":22},{"name":41,"class":42},{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":488,"locationsCount":43},"100645170","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-gastrointestinal-tumors-and-other-solid-tumors-100645170","NCT07678970","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to follow the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic digestive tract tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens within 2 years from the primary or metastatic lesion, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the protocol requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤2+ or ≤1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must not be breastfeeding; all enrolled patients (regardless of male or female) should use adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;\n15. Trial participants are capable of and willing to comply with the visit schedules, treatment plans, laboratory tests, and other study-related procedures as stipulated in the study protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive medications within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior history of ≥ Grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Uncontrolled hypertension;\n10. Diabetic patients with poorly controlled blood glucose;\n11. History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;\n13. Patients with active central nervous system (CNS) metastases;\n14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036;\n15. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n18. Presence of pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n19. Imaging findings indicating that the tumor has invaded or encased the major thoracic blood vessels;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or lactating women;\n24. Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial.",{"count":477,"type":22},10,[25],"This study is an open-label, multicenter, non-randomized Phase I clinical study with dose-escalation and expansion cohorts, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.",[481,154],"Gastrointestinal Tumor","2026-07-15",{"date":484,"type":35},"2026-07-16",{"date":486,"type":22},"2026-07",{"date":39,"type":22},{"name":41,"class":42},""]