First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9

Advanced Solid Cancers

Parts A, B, and C: Occurrence of dose-limiting toxicities (DLTs) within a participant per dose level/cohort., 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 per dose level/cohort., All parts: Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs per dose level/cohort., Part D: Objective response rate (ORR) per dose level/arm. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (based on the investigator’s assessment) is observed as best overall response.

All parts: Assessment of PK parameters derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload per dose level/cohort. Assessment of area under the curve, maximum concentration, time to reach maximum concentration, and terminal half-life, Parts A, B, and C: ORR per dose level/arm. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (based on the investigator’s assessment) is observed as best overall response., All parts: Disease control rate (DCR) Per dose level/arm. Defined as as the proportion of participants in whom a CR or PR or SD (assessed at least 6 weeks is observed as best ORR per investigator’s assessment., All parts: Duration of response (DOR) Per dose level/arm. Defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (PD) or death from any cause, whichever occurs first., All parts: Anti-drug antibody (ADA) prevalence per dose level/cohort. Defined as the proportion of participants who are ADA positive at any timepoint (either baseline or post-baseline) (if data permit)., All parts - ADA incidence per dose level/cohort. Defined as the proportion of participants having treatment-emergent ADA (if data permit).

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