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).
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Part 1 - Occurrence of dose limiting toxicities (DLTs)
Timeframe: During the DLT evaluation period (Cycle 1), i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days
Occurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs
Timeframe: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose
Occurrence of dose interruption, reduction, and discontinuation due to TEAEs
Timeframe: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose
Part 2 - Objective response rate (ORR)
Timeframe: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.
BioNTech clinical trials patient information