[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positivelow-expression-urinary-and-digestive-tract-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positivelow-expression-urinary-and-digestive-tract-tumors":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100518518",false,"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.","ALL","18 Years","75 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.",[27],"Her2-positive\u002FLow-expression Urinary and Digestive Tract Tumors","RECRUITING","2026-04-02",{"date":31,"type":32},"2026-04-08","ACTUAL",{"date":34,"type":32},"2024-01-19",{"date":36,"type":20},"2026-12",{"name":38,"class":39},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",""]