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5W9",{"type":114,"coordinates":388},[389,390],-81.23304,42.98339,{"lat":390,"lon":389},{"facility":393,"status":107,"city":394,"state":39,"zip":395,"country":376,"countryCode":377,"cosmosGeoPoint":396,"geoPoint":400,"contacts":39},"Sunnybrook Health Sciences Centre","Toronto","M4N 3M5",{"type":114,"coordinates":397},[398,399],-79.39864,43.70643,{"lat":399,"lon":398},{"facility":402,"status":107,"city":403,"state":39,"zip":404,"country":376,"countryCode":377,"cosmosGeoPoint":405,"geoPoint":409,"contacts":39},"BC Cancer - Vancouver","Vancouver","V5Z 4E6",{"type":114,"coordinates":406},[407,408],-123.11934,49.24966,{"lat":408,"lon":407},{"facility":411,"status":107,"city":412,"state":39,"zip":413,"country":414,"countryCode":415,"cosmosGeoPoint":416,"geoPoint":420,"contacts":39},"The First Affiliated Hospital of Bengbu Medical 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HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines.\n* Have measurable disease defined by RECIST v1.1.\n* Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization\u002Fenrollment.\n\nKey Exclusion Criteria:\n\n* Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan.\n* Have received any of the following therapies or drugs prior to the initiation of the study:\n\n  * Participants who have received prior treatment with BNT323.\n  * Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) \u002F vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)\u002FVEGF bispecific antibodies, PD-1\u002FPD-L1 inhibitors or anti-VEGF therapies are permitted.\n  * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":811,"type":812},380,"ESTIMATED","INTERVENTIONAL",[815,816],"PHASE1","PHASE2","This is a Phase I\u002FII, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \\[IHC\\] 1+ or IHC 2+\u002Fin situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).",[819,820,821],"Locally Advanced Breast Cancer","Unresectable Breast Carcinoma","Metastatic Breast Cancer",[823,824,825,826,827,828,829,830],"Breast Cancer (BC)","Human epidermal growth factor receptor 2 (HER2)","IHC scores 0, 1+, 2+, and 3+","Antibody drug conjugate (ADC)","Programmed Death-1 (PD-1)","Programmed Death Ligand-1 (PD-L1)","Programmed Death-1 monoclonal antibodies","Anti vascular endothelial growth factor-A (anti-VEGF-A)","2026-09-16",{"date":833,"type":834},"2026-09-17","ACTUAL",{"date":836,"type":834},"2025-04-23",{"date":838,"type":812},"2029-08",{"name":5,"class":6},79]