[{"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:":495},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,42,63,83,102,120,141,160,177,195,214,232,253,272,291,311,329,347,367,385,403,420,437,455,474],{"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":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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",false,"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.","ALL","18 Years","75 Years",{"count":21,"type":22},538,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28],"Biliary Tract Cancer","NOT_YET_RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":22},"2026-07",{"date":37,"type":22},"2028-12",{"name":39,"class":40},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":61,"locationsCount":62},"100634882","phase-3-a-study-comparing-bl-m07d1-with-physicians-choice-of-chemotherapy-in-patients-with-her2-expressing-platinum-resistant-recurrent-epithelial-ovarian-cancer-fallopian-tube-cancer-and-primary-peritoneal-cancer-100634882","NCT07545460","A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer","A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer","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 of signing the informed consent form;\n3. Have an expected survival time of ≥3 months;\n4. Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;\n5. Have previously received a platinum-based regimen and have been confirmed to have platinum-resistant recurrence;\n6. Have received a total of ≥1 and ≤3 prior lines of therapy;\n7. If previously confirmed to be folate receptor alpha (FRα)-positive, must have received treatment with mirvetuximab soravtansine;\n8. Agree to provide archived tumor tissue specimens (from primary or metastatic lesions) collected within 3 years, or fresh tissue samples;\n9. Have at least one measurable lesion as defined by RECIST v1.1;\n10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n11. Have recovered from toxicities of prior anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n12. Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;\n13. Meet the required organ function levels;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, with a negative result, and must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;\n2. Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;\n3. History of severe cardiovascular or cerebrovascular disease within six months before screening;\n4. Concurrent pulmonary disease resulting in severely impaired lung function;\n5. Prolonged QT 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. Unstable thrombotic event requiring therapeutic intervention within 6 months before screening;\n8. Hypertension inadequately controlled by two antihypertensive medications;\n9. Patients with poorly controlled blood glucose levels;\n10. History of ILD treated with steroids, or current ILD, or Grade ≥2 radiation pneumonitis, etc.;\n11. Patients with active central nervous system (CNS) metastases;\n12. Patients with a history of allergy to recombinant humanized antibodies or to any excipient of BL-M07D1;\n13. Prior receipt of organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;\n15. Experienced severe infection within 4 weeks before the first dose of study drug;\n16. Presence of large serosal cavity effusions, or symptomatic serosal cavity effusions, etc.;\n17. Receiving long-term systemic corticosteroid therapy (e.g., \\>10 mg\u002Fday prednisone) prior to randomization;\n18. History of severe neurological or psychiatric disorders;\n19. Experienced serious 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. Intestinal obstruction, 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. Subjects who plan to receive or have received a live vaccine within 28 days before the first dose;\n24. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for this study in the investigator's opinion.",{"count":50,"type":22},404,[25],"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 platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.",[54,55,56],"Epithelial Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer","2026-06-26",{"date":30,"type":33},{"date":35,"type":22},{"date":37,"type":22},{"name":39,"class":40},2,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":70,"minAge":18,"maxAge":19,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":82,"locationsCount":41},"100645174","phase-2-a-study-comparing-bl-m07d1-with-ds-8201-in-patients-with-hr-positive-her2-low-expressing-recurrentmetastatic-breast-cancer-100645174","NCT07678957","A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent\u002FMetastatic Breast Cancer","A Randomized Controlled Phase II Clinical Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent\u002FMetastatic Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements；\n2. Female patients aged ≥18 years and ≤75 years at the time of signing the informed consent form；\n3. Life expectancy ≥12 weeks；\n4. Locally recurrent or metastatic breast cancer that is hormone receptor (HR)-positive and HER2-low expressing；\n5. Provide adequate and recent tumor tissue specimens for central laboratory testing of HER2, HR, and other biomarkers as required；\n6. Meet the prior treatment requirements as specified in the protocol；\n7. Have at least one measurable target lesion per RECIST v1.1 criteria；\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；\n9. Toxicities from prior antitumor therapy have recovered to ≤Grade 1 per NCI-CTCAE v6.0；\n10. Adequate organ function as defined in the protocol；\n11. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment and must be negative; patients must not be breastfeeding. All enrolled patients (both male and female) must use adequate and highly effective contraceptive measures throughout the entire treatment period and for 7 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Received surgery, curative radiotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks prior to the first dose;\n2. Intolerance to the control drug or presence of other contraindications to the control drug;\n3. Prior treatment with anti-HER2 therapy;\n4. Prior treatment with an ADC (antibody-drug conjugate) using a camptothecin derivative as the payload;\n5. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;\n6. Concurrent pulmonary disease resulting in severely impaired lung function;\n7. History of ILD\u002Finterstitial lung disease requiring corticosteroid therapy, etc.;\n8. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n9. Diagnosis of another primary malignancy within 5 years prior to the first dose;\n10. Uncontrolled hypertension;\n11. Active central nervous system (CNS) metastases;\n12. History of severe allergic reactions to any excipient or component of the investigational drug;\n13. History of autologous or allogeneic stem cell transplantation or organ transplantation;\n14. Prior anthracycline treatment with a cumulative equivalent dose of doxorubicin \\> 360 mg\u002Fm²;\n15. Positive for human immunodeficiency virus (HIV) antibody, active hepatitis B virus (HBV) infection, liver cirrhosis, or hepatitis C virus (HCV) infection;\n16. Occurrence of severe infection within 4 weeks prior to the first dose of the investigational drug;\n17. Presence of large-volume serous cavity effusion, or serous cavity effusion with significant symptoms;\n18. Presence of lymphangitic carcinomatosis;\n19. Receiving systemic corticosteroid therapy at a dose of \\> 10 mg\u002Fday prednisone or equivalent prior to randomization;\n20. Presence of severe neurological or psychiatric disorders;\n21. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n22. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;\n23. Planned vaccination or receipt of live vaccine within 28 days prior to the first dose;\n24. Presence of other severe physical conditions, laboratory abnormalities, or poor compliance, which may increase the risk of participating in the study, interfere with the study results, or render the patient unsuitable for enrollment as judged by the investigator.","FEMALE",{"count":72,"type":22},120,[74],"PHASE2","This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast cancer.",[77],"Breast Cancer","2026-06-25",{"date":32,"type":33},{"date":35,"type":22},{"date":37,"type":22},{"name":39,"class":40},{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":101,"locationsCount":41},"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":91,"type":22},16,[93],"PHASE1","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.",[96,97],"Gastrointestinal Tumor","Solid Tumor",{"date":32,"type":33},{"date":35,"type":22},{"date":37,"type":22},{"name":39,"class":40},{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":41},"100637532","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100637532","NCT07606612","A Study of SI-B036 in Patients With Locally Advanced or Metastatic 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 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 solid tumors;\n6. Agree to provide archived tumor tissue specimens from primary or metastatic lesions 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, 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 ≤2+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be 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 treatment completion;\n15. The trial participant is capable and willing to adhere to 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. Receipt of immunosuppressive therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. QT interval prolongation, complete left bundle branch block, etc.;\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 event requiring therapeutic intervention within 6 months prior to the first dose;\n9. Poorly controlled hypertension;\n10. Diabetic patients with poorly controlled blood glucose;\n11. History of ILD requiring steroid therapy, or current ILD, or ≥ grade 2 radiation pneumonitis;\n12. Concomitant pulmonary disease causing severe respiratory impairment;\n13. Active central nervous system metastases;\n14. History of allergy to recombinant humanized or human-mouse chimeric antibodies, or hypersensitivity 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 dose of study drug;\n18. Presence of pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of study drug;\n19. Imaging findings indicating tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;\n20. Study participants with clinically significant bleeding or a clear 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 enrollment in this clinical trial.",{"count":110,"type":22},31,[93],"This study is an open-label, multicenter, non-randomized Phase I clinical study of dose-escalation and expansion to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic solid tumors.",[97],"RECRUITING",{"date":57,"type":33},{"date":117,"type":33},"2026-06-11",{"date":37,"type":22},{"name":39,"class":40},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":62},"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":128,"type":22},90,[74,25],"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.",[132],"Non-small Cell Lung Cancer","2026-06-12",{"date":135,"type":33},"2026-06-15",{"date":137,"type":22},"2026-06",{"date":139,"type":22},"2032-12",{"name":39,"class":40},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":159,"locationsCount":41},"100641600","phase-2-a-study-of-bl-m14d1-in-combination-with-atezolizumab-in-patients-with-extensive-stage-small-cell-lung-cancer-100641600","NCT07654400","A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M14D1 for Injection in Combination With Atezolizumab 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. No gender restriction;\n3. Age: ≥18 years;\n4. Expected survival time ≥3 months;\n5. Histopathologically and\u002For cytologically confirmed extensive-stage small cell lung cancer that is incurable or for which there is currently no standard treatment;\n6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion 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;\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 (LVEF) ≥50%;\n11. Organ function levels must meet the required criteria;\n12. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n13. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment. Serum pregnancy testing must rule out pregnancy, and the patient must not be breastfeeding. All enrolled trial participants (regardless of gender) should take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;\n2. Previous treatment with ADC drugs using topoisomerase I inhibitors as toxins;\n3. Small cell carcinoma with non-small cell carcinoma components indicated by pathology must be excluded;\n4. Use of immunomodulatory drugs within 2 weeks before the first dose of the study;\n5. Receiving long-term systemic corticosteroid therapy at a dose \\>10 mg\u002Fday of prednisone or equivalent before the first dose;\n6. History of severe cardiovascular or cerebrovascular diseases;\n7. Prolonged QTc interval, complete left bundle branch block, etc.;\n8. Active autoimmune diseases and inflammatory diseases;\n9. Diagnosis of another malignancy within 5 years before the first dose;\n10. Hypertension poorly controlled by two antihypertensive drugs;\n11. Patients with poorly controlled blood glucose;\n12. History of ILD\u002Finterstitial pneumonia treated with corticosteroids, etc.;\n13. Concomitant pulmonary diseases leading to clinically severe impairment of respiratory function;\n14. Presence of massive serous cavity effusion, or serous cavity effusion with symptoms, etc.;\n15. Imaging findings indicating that the tumor has invaded or encased major blood vessels in the chest, neck, pharynx, etc.;\n16. Any thrombotic event within 6 months before randomization;\n17. Patients with active central nervous system metastases;\n18. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug, etc.;\n19. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n20. Cumulative anthracycline dose \\>360 mg\u002Fm² during prior (neo)adjuvant anthracycline therapy;\n21. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n22. Active infections requiring systemic treatment, or occurrence of severe infection within 4 weeks before informed consent;\n23. Receipt of other unapproved clinical study drugs or treatments within 4 weeks before the first dose;\n24. Pregnant or breastfeeding women;\n25. History of severe neurological or psychiatric disorders;\n26. Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;\n27. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;\n28. History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection, or presence of Crohn's disease, ulcerative colitis, or chronic diarrhea;\n29. Trial participants who plan to receive or have received live vaccines within 28 days before the first dose;\n30. Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.",{"count":149,"type":22},36,[74],"This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage small cell lung cancer.",[153],"Extensive-stage Small-cell Lung Cancer",{"date":155,"type":33},"2026-06-17",{"date":35,"type":22},{"date":158,"type":22},"2027-12",{"name":39,"class":40},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":175,"leadSponsor":176,"locationsCount":41},"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","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":168,"type":22},446,[25],"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.",[77],"2026-06-10",{"date":135,"type":33},{"date":137,"type":22},{"date":37,"type":22},{"name":39,"class":40},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":193,"leadSponsor":194,"locationsCount":62},"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":185,"type":22},180,[74,25],"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.",[189],"Castration-resistant Prostate Cancer","2026-06-08",{"date":117,"type":33},{"date":137,"type":22},{"date":37,"type":22},{"name":39,"class":40},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":213,"locationsCount":41},"100642227","phase-3-a-study-comparing-bl-b01d1-in-combination-with-osimertinib-versus-osimertinib-alone-in-patients-with-locally-advanced-unresectable-egfr-mutated-non-small-cell-lung-cancerstage-iii-whose-disease-has-not-progressed-following-definitive-platinum-based-chemoradiation-therapypanku-lung08-100642227","NCT07640789","A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age ≥ 18 years and ≤ 75 years, regardless of gender;\n3. Expected survival time ≥ 3 months;\n4. Unresectable Stage III non-small cell lung cancer;\n5. Detection of one of the EGFR-sensitive mutation types in tumor tissue;\n6. Agree to provide archived primary tumor tissue specimens or fresh tissue samples within 1 year;\n7. In platinum-based radical chemoradiotherapy, the platinum-containing chemotherapy regimen must include one of the specified drugs in addition to the platinum agent;\n8. In platinum-based radical chemoradiotherapy, patients must have received a total radiation dose of 60 Gy ± 10% before randomization;\n9. Toxicities from prior chemoradiotherapy must have resolved to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. ECOG performance status score of 0 or 1;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\n12. Organ function levels must meet the requirements;\n13. Urine protein ≤ 1+ or \\\u003C 1000 mg\u002F24h;\n14. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the test must rule out pregnancy; they must not be lactating; all enrolled trial participants must take adequate barrier contraceptive measures throughout the treatment period and for 7 months after treatment ends.\n\nExclusion Criteria:\n\n1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;\n2. The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy;\n3. Major surgery within 4 weeks prior to the first dose;\n4. Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies\u002FADCs targeting EGFR and\u002For HER3;\n5. History of severe heart disease or cerebrovascular disease;\n6. Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n7. Any thrombotic events such as deep vein thrombosis, arterial thrombosis, or pulmonary embolism within 6 months prior to screening;\n8. Diagnosis of active malignancy within 5 years prior to study randomization;\n9. Hypertension poorly controlled by two antihypertensive medications;\n10. Trial participants with poorly controlled blood glucose levels;\n11. Current radiation pneumonitis of Grade ≥2 as defined by CTCAE;\n12. Concurrent lung disease resulting in clinically severe respiratory impairment;\n13. Severe infection within 4 weeks prior to study randomization;\n14. Large serous cavity effusions or symptomatic serous cavity effusions;\n15. Imaging findings suggesting tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;\n16. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;\n17. Trial participants with clinically significant bleeding or a clear tendency for bleeding within 4 weeks prior to signing informed consent;\n18. Trial participants with a history of inflammatory bowel disease, extensive bowel resection, or immune-mediated enteritis;\n19. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug;\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. History of severe neurological or psychiatric disorders, or a history of substance abuse, alcoholism, or drug addiction;\n23. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;\n24. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other reasons.",{"count":203,"type":22},418,[25],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.",[207],"Non-small Cell Lung Cancer Stage III","2026-06-07",{"date":117,"type":33},{"date":137,"type":22},{"date":212,"type":22},"2030-12",{"name":39,"class":40},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":231,"locationsCount":41},"100591927","phase-2-a-study-of-bl-b01d1-monotherapy-bl-b01d1-in-combination-with-lenvatinib-bl-b01d1-in-combination-with-pd-1-monoclonal-antibody-and-bl-b01d1-in-combination-with-pd-1-monoclonal-antibody-and-bevacizumab-in-patients-with-advanced-hepatocellular-carcinoma-100591927","NCT06986785","A Study of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma","A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Gender is not limited;\n3. Age ≥18 years old and ≤75 years old;\n4. Expected survival time ≥3 months;\n5. Patients with advanced HCC confirmed by histology or cytology;\n6. Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. ECOG score was 0-1;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. Organ function level must meet the requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n13. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n14. No cirrhosis or only Child-Pugh A cirrhosis;\n15. If hepatitis B virus infection is negative or positive, the status of HBV surface antigen (HBsAg) should be confirmed by HBV serological test;\n16. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start 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. Patients with active central nervous system metastases;\n2. Who had participated in any other clinical trial within 4 weeks before the trial dose;\n3. Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;\n4. Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;\n5. Systemic corticosteroids or immunosuppressive therapy is required within 2 weeks before study dosing;\n6. Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD\u002Fpulmonary inflammation requiring steroid treatment;\n7. Serious systemic infection within 4 weeks before screening;\n8. Patients at risk for active autoimmune disease or with a history of autoimmune disease;\n9. Other malignant tumors within 5 years before the first treatment;\n10. Human immunodeficiency virus antibody positive, active tuberculosis or hepatitis C virus infection;\n11. Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;\n12. Diabetic patients with poor glycemic control;\n13. Had a history of severe cardiovascular and cerebrovascular diseases;\n14. Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;\n15. Subjects with clinically significant bleeding or significant bleeding tendency within the previous 4 weeks were screened;\n16. Patients with massive or symptomatic effusions or poorly controlled effusions;\n17. Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart;\n18. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n19. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;\n20. Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;\n21. The cumulative dose of anthracyclines \\> 360 mg\u002Fm2 in previous (new) adjuvant therapy;\n22. Pregnant or lactating women;\n23. Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;\n24. Other conditions for trial participation were not considered appropriate by the investigator.",{"count":222,"type":22},74,[74],"This study is a clinical study to explore the efficacy and safety of BL-B01D1 monotherapy, BL-B01D1 in combination with lenvatinib, BL-B01D1 in combination with PD-1 monoclonal antibody, and BL-B01D1 in combination with PD-1 monoclonal antibody and bevacizumab in patients with advanced hepatocellular carcinoma.",[226],"Advanced Hepatocellular Carcinoma",{"date":172,"type":33},{"date":229,"type":33},"2025-06-24",{"date":158,"type":22},{"name":39,"class":40},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":70,"minAge":18,"maxAge":19,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":62},"100632783","phase-3-a-study-of-bl-m07d1-combined-with-pertuzumab-versus-docetaxel-plus-trastuzumab-and-pertuzumab-in-patients-with-first-line-her2-positive-recurrent-or-metastatic-breast-cancer-100632783","NCT07518173","A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer","A Randomized Controlled Phase III Clinical Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;\n3. Expected survival time ≥12 weeks;\n4. Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;\n5. Clear hormone receptor (HR) status;\n6. Agree to provide eligible tumor tissue specimens;\n7. Have at least one measurable target lesion as defined by RECIST v1.1;\n8. 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 v5.0;\n10. Organ function levels must meet the requirements;\n11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and must be non-lactating; all enrolled patients must use adequate and highly effective contraceptive measures throughout the entire treatment period and for 7 months after treatment completion.\n\nExclusion Criteria:\n\n1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.\n2. Previously received ADC drug therapy with camptothecin derivatives as toxins.\n3. History of severe cardiovascular or cerebrovascular disease within six months before screening.\n4. Concomitant pulmonary disease resulting in severely impaired lung function.\n5. History of interstitial lung disease (ILD)\u002Finterstitial pneumonia requiring corticosteroid therapy, etc.\n6. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias.\n7. Diagnosed with another primary malignancy within 5 years before the first dose.\n8. Newly developed deep vein thrombosis within 14 days before screening.\n9. Hypertension poorly controlled by antihypertensive medications.\n10. Patients with active central nervous system metastases.\n11. History of severe allergic reactions to recombinant humanized antibodies or any excipient or component of BL-M07D1.\n12. History of autologous or allogeneic stem cell transplantation or organ transplantation.\n13. Previously received anthracycline therapy exceeding the prescribed dose limit.\n14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection.\n15. Severe infection within 4 weeks prior to the first use of the study drug, etc.\n16. Patients with large serous cavity effusions, serous cavity effusions with obvious symptoms, or poorly controlled serous cavity effusions.\n17. Receiving systemic corticosteroid therapy \\>10 mg\u002Fday prednisone or equivalent prior to randomization, etc.\n18. Presence of severe neurological or psychiatric disorders.\n19. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent.\n20. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.\n21. Subjects planning to receive or having received live vaccines within 28 days before the first dose.\n22. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study in the investigator's opinion.",{"count":240,"type":22},596,[25],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.",[244],"HER2-positive Breast Cancer","2026-06-03",{"date":247,"type":33},"2026-06-04",{"date":249,"type":33},"2026-04-21",{"date":251,"type":22},"2029-12",{"name":39,"class":40},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"locationsCount":41},"100632781","phase-3-a-study-comparing-bl-m05d1-with-the-investigators-choice-of-treatment-regimen-in-patients-with-claudin-cldn182-positive-advanced-gastric-cancer-or-gastroesophageal-junction-adenocarcinoma-gcgejc-who-have-received-prior-first-line-treatment-100632781","NCT07518147","A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJC) Who Have Received Prior First-Line Treatment","A Randomized Controlled Phase III Clinical Study Comparing BL-M05D1 for Injection With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN) 18.2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJC) Who Have Received Prior First-line Treatment","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;\n6. Patients who have failed prior first-line standard therapy must have evidence of radiographic clear progression;\n7. Ability to provide archived or fresh tumor tissue;\n8. Must have at least one measurable lesion as defined by RECIST v1.1;\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n12. Organ function levels must meet the requirements;\n13. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);\n14. Urine protein ≤2+ or \\\u003C1000 mg\u002F24h;\n15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test negative, and 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 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Prior anti-tumor treatment;\n2. Positive HER2 expression in tumor tissue;\n3. History of severe cardiovascular or cerebrovascular disease;\n4. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n6. Active autoimmune diseases and inflammatory diseases;\n7. Diagnosis of another malignancy within 3 years prior to the first dose;\n8. Hypertension poorly controlled by two antihypertensive medications;\n9. History of interstitial lung disease (ILD) requiring hormone therapy, etc.;\n10. Concurrent pulmonary disease resulting in clinically severe respiratory impairment;\n11. Infection requiring clinical intervention within 2 weeks prior to randomization;\n12. Patients with poorly controlled blood glucose levels;\n13. Patients with active central nervous system metastases;\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 such as those in the chest, neck, or pharynx;\n16. History of allergic reactions to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M05D1;\n17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n18. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n19. Active infection requiring systemic treatment;\n20. Pregnant or breastfeeding women;\n21. Esophageal or gastric varices requiring intervention within the past three months, etc.;\n22. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.;\n23. Presence of other serious physical or laboratory abnormalities, or poor compliance, which may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study as judged by the investigator.",{"count":261,"type":22},438,[25],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC\u002FGEJC) who have received prior first-line treatment.",[265,266],"Gastric Cancer","Gastroesophageal Junction Adenocarcinoma",{"date":247,"type":33},{"date":269,"type":33},"2026-05-15",{"date":251,"type":22},{"name":39,"class":40},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":41},"100612616","phase-1-a-study-of-bl-m24d1-in-patients-with-relapsed-or-refractory-multiple-myeloma-and-other-hematologic-malignancies-100612616","NCT07255898","A Study of BL-M24D1 in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M24D1 for Injection in Patients With Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Gender is not restricted;\n3. Age: ≥18 years and ≤75 years (Phase Ia); ≥18 years (Phase Ib);\n4. Expected survival time ≥3 months;\n5. Histologically and\u002For cytologically confirmed multiple myeloma or other hematologic malignancies that have failed standard treatment or for which no standard treatment currently exists;\n6. Must have measurable indicators as defined by the protocol;\n7. Physical condition score ECOG 0 or 1;\n8. Toxicity from previous antitumor treatments has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n9. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n10. Organ function levels must meet the requirements;\n11. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;\n12. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, the serum pregnancy test must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should adopt adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Subjects with central nervous system involvement, etc.;\n2. Use of chemotherapy, biologics, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;\n3. History of severe heart disease;\n4. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Diagnosis of other malignancies within 5 years prior to the first dose;\n7. Hypertension poorly controlled by two antihypertensive medications;\n8. Patients with poorly controlled blood glucose;\n9. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n10. Lung diseases defined as ≥ Grade 3 according to CTCAE v5.0; history of interstitial lung disease requiring hormone treatment, etc.;\n11. Patients with peripheral neuropathy ≥ Grade 3 or persistent ≥ Grade 2 peripheral neuropathy with pain;\n12. Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M24D1;\n13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n14. Human immunodeficiency virus antibody positivity, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n15. Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration, etc.;\n16. Pleural, abdominal, pelvic, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n17. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first study drug administration;\n18. Participation in another clinical trial within 4 weeks prior to the first dose;\n19. Pregnant or breastfeeding women;\n20. Patients who received live vaccines within 30 days prior to the first dose;\n21. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":280,"type":22},33,[93],"This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-M24D1 in patients with relapsed or refractory multiple myeloma and other hematologic malignancies.",[284,285],"Multiple Myeloma","Hematologic Malignancies",{"date":247,"type":33},{"date":288,"type":33},"2026-03-25",{"date":158,"type":22},{"name":39,"class":40},{"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":114,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":310,"locationsCount":41},"100639242","phase-1-a-study-of-bl-arc002-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100639242","NCT07591155","A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-ARC002 for Injection in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);\n4. Expected survival time ≥3 months;\n5. Histopathologically and\u002For cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 2 years;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group performance status of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\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 ≤2+ or ≤1000 mg\u002F24 hours;\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 breastfeeding; all enrolled patients (regardless of sex) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of serious heart 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 malignancy within 5 years prior to the first dose;\n6. Hypertension inadequately controlled by two antihypertensive medications;\n7. History of ILD requiring steroid therapy, current ILD, or ≥ Grade 2 radiation pneumonitis;\n8. Active symptoms of central nervous system metastasis;\n9. History of allergy to recombinant humanized 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 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. Pregnancy or breastfeeding;\n16. Study participants with claustrophobia or any condition preventing them from lying still to complete examinations;\n17. Other conditions deemed by the investigator to make the participant unsuitable for this clinical trial.",{"count":299,"type":22},22,[93],"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 BL-ARC002 for injection in patients with locally advanced or metastatic solid tumors.",[303],"Solid Tumors","2026-05-26",{"date":306,"type":33},"2026-05-28",{"date":308,"type":33},"2026-05-13",{"date":158,"type":22},{"name":39,"class":40},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":328,"locationsCount":62},"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":319,"type":22},398,[25],"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.",[28],"2026-05-19",{"date":304,"type":33},{"date":326,"type":22},"2026-05",{"date":37,"type":22},{"name":39,"class":40},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":345,"leadSponsor":346,"locationsCount":41},"100639761","phase-1-a-study-of-bl-m11d1-in-patients-with-relapsedrefractory-myelodysplastic-syndromes-100639761","NCT07591168","A Study of BL-M11D1 in Patients With Relapsed\u002FRefractory Myelodysplastic Syndromes","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-M11D1 for Injection in Patients With Relapsed\u002FRefractory Myelodysplastic Syndromes","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Relapsed\u002Frefractory CD33+ MDS;\n6. Morphological assessment showing blasts in bone marrow ≥5% and \\\u003C20%;\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;\n8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n9. Meet the required organ function levels;\n10. For premenopausal women of childbearing potential, a pregnancy test (serum\u002Furine) must be negative within 7 days before starting treatment, and they must not be breastfeeding; all enrolled trial participants (regardless of gender) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. Presence of uncorrected folate deficiency or vitamin B12 deficiency, etc.;\n3. History of severe cardiovascular or cerebrovascular disease;\n4. Thromboembolic events requiring therapeutic intervention within 6 months prior to screening;\n5. Active autoimmune diseases and inflammatory diseases;\n6. History of extensive bowel resection or presence of Crohn's disease, ulcerative colitis, chronic diarrhea, or intestinal obstruction;\n7. Diagnosis of another malignancy within 5 years prior to the first dose;\n8. Poorly controlled hypertension;\n9. Poorly controlled hyperglycemia or diabetes mellitus;\n10. Pulmonary diseases classified as Grade ≥3 according to CTCAE v6.0, etc.;\n11. Trial participants with central nervous system involvement;\n12. Trial participants with extramedullary involvement;\n13. Trial participants with a history of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or hypersensitivity to any excipient component of BL-M11D1;\n14. Prior organ transplantation or 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 fungal, bacterial, or viral infections;\n17. History of severe neurological or psychiatric disorders;\n18. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n19. Presence of clinically symptomatic pleural, peritoneal, or pericardial effusion requiring repeated drainage;\n20. Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose;\n21. Pregnant or breastfeeding women;\n22. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.",{"count":337,"type":22},92,[93,74],"This study is an open-label, multicenter, non-randomized Phase Ib\u002FII clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of BL-M11D1 for injection in patients with relapsed\u002Frefractory myelodysplastic syndromes.",[341],"Myelodysplastic Syndromes","2026-05-09",{"date":269,"type":33},{"date":326,"type":22},{"date":37,"type":22},{"name":39,"class":40},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":366,"locationsCount":41},"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":355,"type":22},570,[74],"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.",[132,359,97],"Nasopharyngeal Carcinoma","2026-04-30",{"date":362,"type":33},"2026-05-06",{"date":364,"type":33},"2024-06-25",{"date":35,"type":22},{"name":39,"class":40},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":384,"locationsCount":41},"100635574","phase-2-a-study-of-bl-b01d1-in-combination-with-tislelizumab-5-fluorouracil-versus-platinum-based-chemotherapy-plus-tislelizumab-as-first-line-treatment-in-patients-with-unresectable-locally-advanced-recurrent-or-metastatic-esophageal-squamous-cell-carcinomapanku-esophagus02-100635574","NCT07554456","A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)","A Phase II\u002FIII Randomized Controlled Clinical Study of BL-B01D1 for Injection in Combination With Tislelizumab With or Without 5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma","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 at the time of signing the informed consent form;\n4. Expected survival time ≥3 months;\n5. Patients with unresectable, locally advanced recurrent or metastatic first-line esophageal squamous cell carcinoma;\n6. Must have at least one measurable target lesion as defined by RECIST v1.1;\n7. Must provide archived tumor tissue specimens from the primary or metastatic lesion within the past 3 years;\n8. Eastern Cooperative Oncology Group (ECOG) performance status 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; left ventricular ejection fraction ≥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 \\\u003C1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must be negative, and the patient must not be breastfeeding; 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.\n\nExclusion Criteria:\n\n1. Patients with esophageal squamous cell carcinoma whose pathology indicates the presence of non-squamous carcinoma components;\n2. Use of immunomodulatory drugs within 2 weeks prior to the first study drug administration;\n3. Prior use of an ADC drug whose small-molecule toxin is a topoisomerase I inhibitor;\n4. Patients with esophageal squamous cell carcinoma who are suitable for curative-intent local therapy;\n5. Receipt of curative-intent radiotherapy, major surgery, etc., within 4 weeks prior to study randomization;\n6. Ongoing long-term systemic corticosteroid therapy (e.g., \\>10 mg\u002Fday prednisone) prior to the first dose;\n7. Prior immunotherapy targeting PD-1, PD-L1, or PD-L2;\n8. History of severe heart disease or cerebrovascular disease;\n9. Prolonged QTc interval, complete left bundle branch block, etc.;\n10. Active autoimmune diseases and inflammatory diseases;\n11. Diagnosis of active malignant tumor within 3 years prior to study randomization;\n12. Hypertension poorly controlled by two antihypertensive agents;\n13. Patients with poorly controlled blood glucose;\n14. History of interstitial lung disease (ILD)\u002Finterstitial pneumonitis requiring steroid therapy, etc.;\n15. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n16. Presence of large serous cavity effusions or serous cavity effusions, etc.;\n17. Concomitant pulmonary diseases resulting in clinically severe respiratory function impairment;\n18. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, thorax, neck, or pharynx;\n19. Tumor invasion or compression of the trachea or bronchi causing any clinical symptoms such as cough;\n20. Patients with esophageal fistula caused by tumor invasion of adjacent organs, or patients assessed by the investigator as being at risk of developing esophageal fistula;\n21. Patients with tracheal or esophageal stent placement due to any cause;\n22. Participants with clinically significant bleeding or an obvious bleeding tendency within 4 weeks prior to signing the informed consent form;\n23. BMI \\\u003C 18.5 kg\u002Fm² at screening, or weight loss ≥10% within 2 months prior to screening;\n24. Patients with active central nervous system metastases;\n25. Patients with a history of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient component of BL-B01D1;\n26. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n27. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n28. Severe infection within 4 weeks prior to study randomization, etc.;\n29. History of severe neurological or psychiatric disorders;\n30. Patients with a history of substance abuse that precludes compliance with clinical trial requirements;\n31. Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;\n32. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.;\n33. Receipt of other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;\n34. Trial participants planning to receive or having received live vaccine within 28 days prior to the first dose;\n35. Pregnant or breastfeeding women;\n36. Presence of other serious physical conditions, laboratory abnormalities, or poor compliance that may increase the risk of study participation, interfere with study results, or make the patient unsuitable for study participation in the investigator's opinion.",{"count":128,"type":22},[74,25],"This trial is a registrational Phase II\u002FIII, randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with tislelizumab ± 5-FU in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.",[378],"Esophageal Squamous Cell Carcinoma",{"date":380,"type":33},"2026-04-28",{"date":382,"type":22},"2026-04",{"date":37,"type":22},{"name":39,"class":40},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":401,"leadSponsor":402,"locationsCount":62},"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":393,"type":22},562,[25],"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.",[153],"2026-04-15",{"date":399,"type":33},"2026-04-20",{"date":382,"type":22},{"date":251,"type":22},{"name":39,"class":40},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":419,"locationsCount":41},"100592497","phase-3-a-study-comparing-bl-b01d1-with-the-investigators-choice-of-chemotherapy-in-patients-with-platinum-resistant-recurrent-epithelial-ovarian-cancerpanku-gyn01-100592497","NCT06994195","A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age: ≥18 years old;\n3. Expected survival time ≥3 months;\n4. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;\n5. Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence;\n6. Previously received 1-3 lines of systemic anti-tumor therapy, with radiographic evidence of disease progression during or after the last line of treatment or intolerance to the current treatment prior to randomization;\n7. For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine;\n8. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years;\n9. Must have at least one measurable lesion as defined by RECIST v1.1;\n10. ECOG performance status score of 0 or 1;\n11. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n12. No severe cardiac dysfunction, with 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) ≤1.5×ULN;\n15. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients should use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives prior to study randomization and palliative radiotherapy, etc., within 2 weeks;\n2. Patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy;\n3. Front line received ADCs targeting topoisomerase I inhibitors or EGFR and\u002For HER3;\n4. History of severe heart disease and cerebrovascular disease;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;\n6. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n7. Diagnosed with active malignancy within 3 years before randomization;\n8. Hypertension poorly controlled by two antihypertensive drugs;\n9. Patients with poor glycemic control;\n10. Patients with grade ≥1 radiation pneumonitis according to the RTOG\u002FEORTC definition; Previous history of ILD;\n11. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n12. Patients with active central nervous system metastases;\n13. Severe infection occurred within 4 weeks before randomization in study 13; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;\n14. Patients with massive or symptomatic effusions or poorly controlled effusions;\n15. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;\n16. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;\n17. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n18. Patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;\n19. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;\n20. Had a history of autologous or allogeneic stem cell transplantation;\n21. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;\n22. A history of severe neurological or psychiatric illness;\n23. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;\n24. Subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization;\n25. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.",{"count":411,"type":22},384,[25],"This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.",[54,55,56],{"date":399,"type":33},{"date":417,"type":33},"2025-08-04",{"date":158,"type":22},{"name":39,"class":40},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":436,"locationsCount":41},"100580513","phase-3-a-study-of-bl-b01d1-in-combination-with-osimertinib-versus-osimertinib-as-first-line-treatment-in-patients-with-egfr-mutated-locally-advanced-or-metastatic-non-small-cell-lung-cancerpanku-lung04-100580513","NCT06838273","A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)","A Phase III Randomized Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Age ≥18 years old;\n3. Expected survival time ≥3 months;\n4. Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer;\n5. Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;\n6. Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type;\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 severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. The organ function level must meet the requirements on the premise that blood transfusion and colony-stimulating factor are not allowed within 14 days before the screening period;\n12. Urinary protein ≤2+ or \\\u003C 1000mg\u002F24h;\n13. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be 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. Previous histologic or cytological evidence of small cell or mixed small\u002Fnon-small cell components;\n2. Patients with previous systemic therapy;\n3. Patients had received EGFR-TKI therapy;\n4. Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;\n5. History of severe heart disease and cerebrovascular disease;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;\n7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n8. Were diagnosed with active malignancy within 3 years before randomization;\n9. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg);\n10. Patients with poor glycemic control;\n11. A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease;\n12. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n13. Patients with active central nervous system metastasis;\n14. Had a severe infection within 4 weeks before randomization;\n15. Patients with massive or symptomatic effusions or poorly controlled effusions;\n16. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;\n17. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;\n18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n19. Patients with a history of inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;\n20. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;\n21. Had autologous or allogeneic stem cell transplantation history;\n22. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;\n23. A history of severe neurological or psychiatric illness;\n24. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;\n25. Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;\n26. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.",{"count":428,"type":22},720,[25],"This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.",[132],{"date":399,"type":33},{"date":434,"type":33},"2025-02-24",{"date":37,"type":22},{"name":39,"class":40},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":454,"locationsCount":41},"100581966","phase-3-a-study-comparing-bl-b01d1-with-chemotherapy-of-physicians-choice-in-patients-with-recurrent-or-metastatic-urothelial-carcinomapanku-bladder01-100581966","NCT06857175","A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma After Failure of PD-1\u002FPD-L1 Monoclonal Antibody and Platinum-based Chemotherapy","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Age: ≥18 years old;\n3. Expected survival time ≥3 months;\n4. Patients with unresectable locally advanced or metastatic urothelial carcinoma who had failed platinum-based chemotherapy and PD-1\u002FPD-L1 inhibitors;\n5. Patients with locally advanced or metastatic urothelial carcinoma who are eligible for treatment with the control chemotherapy agents specified in this protocol;\n6. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 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 severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. If blood transfusion and colony-stimulating factor were not allowed within 14 days before randomization, the organ function level had to meet the requirements;\n12. A serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal women of childbearing potential, and the result must be negative and 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. Chemotherapy, targeted therapy, biological therapy, etc. were used within 4 weeks or 5 half-lives before randomization;\n2. Patients with locally advanced or metastatic urothelial carcinoma who were suitable for radical local therapy were excluded;\n3. Frontline received ADCs targeting topoisomerase I inhibitors or EGFR and\u002For HER3; The front line had received both paclitaxel and docetaxel;\n4. History of severe heart disease and cerebrovascular disease;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;\n6. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n7. Diagnosed with active malignancy within 3 years before randomization;\n8. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg);\n9. Patients with poor glycemic control;\n10. Patients with grade ≥1 radiation pneumonitis according to the RTOG\u002FEORTC definition; Previous history of ILD, or suspicion of such disease during screening;\n11. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n12. Patients with active central nervous system metastases;\n13. Severe infection occurred within 4 weeks before randomization; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;\n14. Patients with massive or symptomatic effusions or poorly controlled effusions;\n15. Imaging examination indicated that the tumor had invaded or wrapped around the large blood vessels of the abdomen, chest, neck, and pharynx, except for those that the investigator thought would not affect the patient's enrollment in the drug;\n16. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;\n17. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n18. Patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;\n19. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;\n20. Had a history of autologous or allogeneic stem cell transplantation;\n21. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;\n22. A history of severe neurological or psychiatric illness;\n23. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;\n24. Subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization;\n25. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.",{"count":445,"type":22},508,[25],"This trial is a registered phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic urothelial carcinoma after failure of PD-1\u002FPD-L1 monoclonal antibody and platinum-based chemotherapy.",[449],"Urothelial Carcinoma",{"date":399,"type":33},{"date":452,"type":33},"2025-03-25",{"date":158,"type":22},{"name":39,"class":40},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":41},"100571312","phase-1-a-study-of-bl-m08d1-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100571312","NCT06718621","A Study of BL-M08D1 in Patients With Locally Advanced or Metastatic Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Gender is not limited;\n3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic solid tumors confirmed by histopathology and\u002For cytology that are incurable or currently have no standard treatment;\n6. Consent to provide archival tumor tissue samples or fresh tissue samples from 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 severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. 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;\n12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;\n13. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment;\n15. Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Chemotherapy, biological therapy and other anti-tumor therapies have 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; Oral drugs such as fluorouracil;\n2. History of severe heart disease;\n3. QT prolongation, complete left bundle branch block, III degree atrioventricular block;\n4. Active autoimmune and inflammatory diseases;\n5. Other malignant tumors diagnosed within 5 years before the first dose;\n6. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg);\n7. History of ILD requiring steroid therapy or current ILD or ≥ grade 2 radiation pneumonitis;\n8. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n9. Had symptoms of active central nervous system metastasis;\n10. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M08D1;\n11. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n12. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;\n13. Active infection requiring systemic therapy within 4 weeks before the first dose of study drug;\n14. Pleural, abdominal, pelvic or pericardial effusion requiring drainage and\u002For with symptoms within 4 weeks before the first dose of study drug;\n15. Received another trial drug 4 weeks or 5 half-lives before the first dose;\n16. Pregnant or lactating women;\n17. The investigator did not consider it appropriate to apply other criteria for participation in the trial.",{"count":299,"type":22},[93],"This study is an open, multicenter, dose-escalation and expansion-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M08D1 for injection in locally advanced or metastatic solid tumors.",[97],"2026-04-09",{"date":468,"type":33},"2026-04-14",{"date":470,"type":33},"2025-02-12",{"date":472,"type":22},"2027-06",{"name":39,"class":40},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":41},"100518518","phase-1-a-study-of-bl-m07d1-in-patients-with-a-variety-of-solid-tumors-including-locally-advanced-or-metastatic-her2-positivelow-expressing-urinary-and-gastrointestinal-tumors-100518518","NCT06031584","A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive\u002FLow-expressing Urinary and Gastrointestinal Tumors","A Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-positive\u002FLow-expressing Urinary and Gastrointestinal Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Patients with unresectable locally advanced or metastatic HER2-positive\u002Flow-expressing urological and digestive system tumors, as well as other solid tumors;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 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. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;\n13. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n14. Albumin ≥30 g\u002FL;\n15. For premenopausal women with childbearing potential, a pregnancy test (serum\u002Furine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 7 months after treatment ends.\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;\n2. Previously treated with ADC drugs containing camptothecin derivatives as payloads;\n3. History of severe cardiovascular or cerebrovascular diseases;\n4. Active autoimmune or inflammatory diseases;\n5. History of other malignancies within 5 years prior to the first dose;\n6. Thrombotic events requiring therapeutic intervention within 6 months before screening;\n7. Patients with significant pleural\u002Fperitoneal\u002Fpelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;\n8. Poorly controlled hypertension despite antihypertensive medication;\n9. Current interstitial lung disease, drug-induced interstitial pneumonitis, radiation pneumonitis requiring steroid treatment, or history of these conditions;\n10. Patients with primary central nervous system (CNS) tumors or CNS metastases that failed local treatment;\n11. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-M07D1;\n12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n13. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, or active hepatitis C virus (HCV) infection;\n14. Active hepatitis B virus (HBV) infection (exclusion criterion);\n15. Severe infection requiring systemic treatment within 4 weeks before the first dose of the study drug;\n16. Participation in another clinical trial within 4 weeks before the first dose;\n17. Pregnant or lactating women;\n18. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.",{"count":482,"type":22},42,[93,74],"Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors. Phase II: To explore the efficacy of BL-M07D1 in patients with a variety of solid tumors including locally advanced or metastatic HER2-positive\u002Flow-expressing urinary and gastrointestinal tumors.",[486],"Her2-positive\u002FLow-expression Urinary and Digestive Tract Tumors","2026-04-02",{"date":489,"type":33},"2026-04-08",{"date":491,"type":33},"2024-01-19",{"date":493,"type":22},"2026-12",{"name":39,"class":40},""]