[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"digestive-tract-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:digestive-tract-tumors":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100652820","phase-1-a-study-of-bl-m08d-in-patients-with-locally-advanced-or-metastatic-digestive-tract-tumors-and-other-solid-tumors-100652820",false,"NCT07780318","A Study of BL-M08D in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic gastrointestinal tumors and other solid tumors;\n6. Agree to provide archival tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to the first dose;\n9. Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n13. Urine protein ≤1+ or ≤1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy results being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after the completion of treatment;\n15. The trial participant is capable and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe cardiac or cerebrovascular disease;\n3. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of another malignant tumor within 5 years prior to the first dose;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension inadequately controlled by antihypertensive medication;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease requiring hormone therapy, or current ILD, or radiation pneumonitis of Grade ≥2;\n10. Severe impairment of respiratory function;\n11. Active central nervous system metastases;\n12. Previous or concurrent central nervous system disorders;\n13. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;\n14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n15. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n16. Active infection requiring systemic treatment within 4 weeks prior to the first study drug administration;\n17. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n18. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, cervical, or other regions;\n19. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n20. Pregnant or breastfeeding women;\n21. Other conditions deemed by the investigator to make the patient unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This Phase Ib\u002FII study is a clinical trial exploring the efficacy and safety of BL-M08D1 for injection in patients with locally advanced or metastatic digestive tract tumors and other solid tumors.",[28,29],"Digestive Tract Tumors","Solid Tumors","NOT_YET_RECRUITING","2026-08-19",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":21},"2026-09",{"date":38,"type":21},"2028-12",{"name":40,"class":41},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY"]