The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are. The second goal of this study is to evaluate how well BNT329 works. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured. The study will also evaluate how BNT329 moves into, through, and out of the body and how the treatment affects the body.
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Parts A, B, and C - Occurrence of dose-limiting toxicities within a participant
Timeframe: First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
All parts - 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 first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).
All parts - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs
Timeframe: From the time of initiation of the first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).
Part D - Objective response rate (ORR)
Timeframe: From first dose of BNT329 until end of study (up to approximately 36 months).
BioNTech clinical trials patient information