[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652096":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":19,"overallStatus":71,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BL-M09D1","EXPERIMENTAL","Participants receive BL-M09D1 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.",[13],"Drug: BL-M09D1",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Administration by intravenous infusion for a cycle of 3 weeks.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Sa Xiao, PHD","CONTACT","+8615013238943","xiaosa@baili-pharm.com",[27],{"facility":28,"status":19,"city":29,"state":30,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Fujian Cancer Hospital","Fuzhou","Fujian","China","CN",{"type":34,"coordinates":35},"Point",[36,37],119.30611,26.06139,{"lat":37,"lon":36},[40,44],{"name":41,"role":23,"phone":42,"phoneExt":19,"email":43},"Yang Sun","15959028989","gcpsunyang@sina.com",{"name":41,"role":45,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[49],{"name":50,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100652096","phase-2-a-study-of-bl-m09d1-in-patients-with-locally-advanced-or-metastatic-gynecological-malignancies-and-other-solid-tumors-100652096",false,"NCT07769229","A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors","A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. Female;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Diagnosed with endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma, or other solid tumors;\n6. Patients with locally advanced or metastatic gynecological malignancies and other solid tumors who have failed standard treatment or are intolerant to standard treatment;\n7. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;\n8. Must have at least one measurable lesion as defined by RECIST v1.1;\n9. Eastern Cooperative Oncology Group performance status of 0 or 1;\n10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n12. Organ function levels must meet the protocol requirements;\n13. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n14. Urine protein ≤1+ or ≤1000 mg\u002F24h;\n15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment;\n16. The trial participant is capable and willing to comply with the scheduled visits, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe heart disease;\n3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune disease or inflammatory disease;\n5. Diagnosis of active malignancy within 3 years prior to study randomization;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension inadequately controlled by two antihypertensive agents;\n8. Poorly controlled blood glucose;\n9. History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;\n10. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;\n11. Active central nervous system metastases;\n12. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M09D1;\n13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n15. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n16. Pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n17. Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose;\n18. Clinically significant bleeding or marked bleeding tendency within 4 weeks prior to the first study drug administration;\n19. Inflammatory bowel disease requiring symptomatic or drug intervention, or partial\u002Fcomplete intestinal obstruction within 4 weeks prior to the first study drug administration;\n20. Known psychiatric disorders that may affect compliance with the trial;\n21. Planned vaccination or administration of live vaccine within 28 days prior to the first dose;\n22. Pregnant or breastfeeding women;\n23. Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical trial.","FEMALE","18 Years","75 Years",{"count":62,"type":63},126,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","This study is a single-arm, open-label, multicenter, non-randomized phase II clinical study evaluating the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic gynecological malignancies and other solid tumors.",[69,70],"Gynecological Malignancies","Solid Tumors","NOT_YET_RECRUITING","2026-08-12",{"date":74,"type":75},"2026-08-17","ACTUAL",{"date":77,"type":63},"2026-08",{"date":79,"type":63},"2028-12",{"name":5,"class":6},1]