[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649137":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":34,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":34,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":34,"overallStatus":90,"whyStopped":34,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"BL-B01D1+PD-1 monoclonal antibody","EXPERIMENTAL","Participants receive BL-B01D1+PD-1 monoclonal antibody in 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.",[13,14],"Drug: BL-B01D1","Drug: PD-1 monoclonal antibody",{"label":16,"type":17,"description":18,"interventionNames":19},"nab-paclitaxel+PD-1 monoclonal antibody","ACTIVE_COMPARATOR","Participants receive nab-paclitaxel+PD-1 monoclonal antibody in 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.",[14,20],"Drug: Nab-paclitaxel",[22,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","BL-B01D1","Administration by intravenous infusion for a cycle of 3 weeks.",[9],[28,29,30],"iza-bren","izalontamab brengitecan","BMS-986507",{"type":23,"name":32,"description":25,"armGroupLabels":33,"otherNames":34},"PD-1 monoclonal antibody",[9,16],null,{"type":23,"name":36,"description":25,"armGroupLabels":37,"otherNames":34},"Nab-paclitaxel",[16],[39],{"name":40,"role":41,"phone":42,"phoneExt":34,"email":43},"Sa Xiao, PHD","CONTACT","+8615013238943","xiaosa@baili-pharm.com",[45],{"facility":46,"status":34,"city":47,"state":48,"zip":34,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","China","CN",{"type":52,"coordinates":53},"Point",[54,55],121.45806,31.22222,{"lat":55,"lon":54},[58,62,64],{"name":59,"role":41,"phone":60,"phoneExt":34,"email":61},"Jiong Wu","021-64175590-73546","wujiong1122@vip.sina.xn",{"name":59,"role":63,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"name":65,"role":63,"phone":34,"phoneExt":34,"email":34},"Jian Zhang",{"type":67,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[69],{"name":70,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100649137","phase-3-a-study-of-bl-b01d1-plus-an-anti-pd-1-antibody-versus-nab-paclitaxel-plus-an-anti-pd-1-antibody-in-patients-with-previously-untreated-locally-advanced-inoperable-or-metastatic-triple-negative-breast-cancer-whose-tumors-express-pd-l1-panku-breast04-100649137",false,"NCT07729956","A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)","A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. Female patients aged 18 to 75 years;\n3. Expected survival time ≥ 3 months;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. Pathologically confirmed recurrent or metastatic triple-negative breast cancer;\n6. Confirmed PD-L1 expression positivity by central laboratory testing;\n7. No prior systemic anti-tumor therapy in the advanced\u002Frecurrent or metastatic setting;\n8. Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;\n9. Must have at least one measurable lesion as defined by RECIST v1.1;\n10. Toxicities 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 (LVEF) ≥ 50%;\n12. Organ function levels must meet the protocol-specified requirements;\n13. Urine protein ≤ 1+ or \\\u003C 1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test (serum) must be performed within 7 days before starting treatment, and pregnancy must be ruled out; patients must not be lactating. All enrolled patients (regardless of sex) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;\n2. Prior exposure to ADC drugs with topoisomerase I inhibitor payload;\n3. Prior treatment with other T-cell receptor-targeting agents (excluding PD-1\u002FPD-L1);\n4. Use of immunomodulators within 14 days before the first study drug dose;\n5. History of severe cardiac or cerebrovascular disease;\n6. Receiving chronic systemic corticosteroids at \\>10 mg\u002Fday prednisone before the first dose;\n7. Active autoimmune or inflammatory disease;\n8. Any thrombotic event within 6 months before randomization;\n9. Prolonged QTc, complete left bundle branch block, or similar;\n10. Active malignancy diagnosed within 3 years before randomization;\n11. Hypertension uncontrolled by two antihypertensives;\n12. Poorly controlled diabetes\u002Fhyperglycemia;\n13. History of steroid-treated ILD\u002Finterstitial pneumonitis;\n14. Concurrent lung disease causing clinically significant respiratory impairment;\n15. Active CNS metastases;\n16. Severe infection within 4 weeks before randomization;\n17. Massive or symptomatic serosal effusion;\n18. Severe non-healing wound, ulcer, or fracture within 4 weeks before consent;\n19. Clinically significant bleeding or bleeding tendency within 4 weeks before consent;\n20. Inflammatory bowel disease, extensive bowel resection, immune enteritis, bowel obstruction, or chronic diarrhea;\n21. Allergy or contraindication to the study drug;\n22. History of autologous\u002Fallogeneic stem cell transplantation;\n23. HIV antibody positive, active HBV, or active HCV;\n24. History of severe neurological or psychiatric illness;\n25. Received or planning to receive live vaccine within 28 days before randomization;\n26. Other conditions rendering the patient unsuitable per investigator's judgment.","FEMALE","18 Years","75 Years",{"count":82,"type":83},436,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.",[89],"Triple-Negative Breast Cancer (TNBC)","NOT_YET_RECRUITING","2026-07-22",{"date":93,"type":94},"2026-07-28","ACTUAL",{"date":96,"type":83},"2026-08",{"date":98,"type":83},"2029-12",{"name":5,"class":6},1]