Stopped: Sponsor decision
This study is an open-label, multicenter, Phase I/IIa, dose escalation, safety, and pharmacokinetics (PK) study of BNT142 followed by expansion cohorts in patients with Claudin 6 (CLDN6)-positive advanced tumors.
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) including Grade ≥3, serious, or fatal TEAEs by causal relationship to study treatment
Timeframe: From first dose to 60 days after the last dose of BNT142
Occurrence of dose reductions and discontinuation of BNT142 due to TEAEs
Timeframe: From first dose to 60 days after the last dose of BNT142
Part 1: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period in the dose escalation
Timeframe: Assessed during the DLT period, i.e., up to 5 weeks after first dose of BNT142
Part 2: Objective response rate (ORR)
Timeframe: Up to 36 months after last patient last dose