[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518518":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study treatment","EXPERIMENTAL","Participants received BL-M07D1 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.",[13],"Drug: BL-M07D1",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","BL-M07D1","BL-M07D1 was administered by intravenous infusion every 3 weeks in 3-week cycles.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Aiping Zhou, PHD","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Sa Xiao, PHD","CONTACT","+8615013238943","xiaosa@baili-pharm.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":23,"role":29,"phone":20,"phoneExt":20,"email":20},{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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",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":61,"type":62},42,"ESTIMATED","INTERVENTIONAL",[65,66],"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.",[69],"Her2-positive\u002FLow-expression Urinary and Digestive Tract Tumors","2026-04-02",{"date":72,"type":73},"2026-04-08","ACTUAL",{"date":75,"type":73},"2024-01-19",{"date":77,"type":62},"2026-12",{"name":5,"class":6},1]