This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment emergent serious adverse events (SAEs)
Timeframe: up to 100 days after the last dose of treatment
Occurrence of dose interruption, dose reduction, and discontinuation of study treatment due to adverse events (AEs)
Timeframe: up to 100 days after the last dose of treatment
Objective Response Rate (ORR)
Timeframe: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment
Best percentage change from baseline in the tumor size
Timeframe: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment
Proportion of participants who have achieved early tumor shrinkage
Timeframe: up to 4 months after first dose of treatment