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A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

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研究单位： [1]BioNTech SE [2]DualityBio Inc. [3]Biotheus Inc. [4]BioNTech (Shanghai) Pharmaceuticals Co., Ltd. [5]Hematology - Oncology Associates of the Treasure Coast,Port Saint Lucie 4169171,Florida 4155751,United States,34952 [6]START Midwest, LLC,Grand Rapids 4994358,Michigan 5001836,United States,49546 [7]South Texas Accelerated Research Therapeutics (START), LLC,San Antonio 4726206,Texas 4736286,United States,78229 [8]Sichuan Cancer Hospital,Chengdu 1815286,China,610072 [9]Huizhou First Hospital,Huizhou 1806776,China,516003 [10]Fudan University Shanghai Cancer,Shanghai 1796236,China,201315 [11]Institute of Oncology Arensia Exploratory Medicine,Chisinau 618426,Moldova,2025

关键词： 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)

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This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 in combination with BNT327 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+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).