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.
Have an Eastern Cooperative Oncology Group performance score of 0 to 1
Have measurable disease per RECIST v1.1, except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria.
Have a life expectancy of ≥3 months in the opinion of the investigator.
Have adequate organ, coagulation, and hematologic function as defined in the protocol.
Are enrolled in another investigational study or are subject to exclusion periods from another investigational study.
Have had an inadequate washout period for prior anticancer treatment prior to the first dose of investigational medicinal product (IMP) as defined in the protocol.
Inhaled sprays, topical steroids, or local steroid injections (e.g., intra-articular injection).
Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).
Sequential
BNT329
DrugIntravenous (IV) infusion
CA19-9-targeting monoclonal antibody
DrugMonoclonal antibody
Parts A and B - Occurrence of dose-limiting toxicities within a participant
Per dose level.
Parts A, B, and D - 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.
Parts A, B, and D - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs
Per dose level.
Part D - Objective response rate (ORR)
Per dose level. 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.
Parts A, B, and D - Assessment of area under the curve derived from serum/plasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
Per dose level (if data permit)
Parts A, B, and D - Assessment of maximum concentration derived from serum/plasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
Per dose level (if data permit).
Parts A, B, and D - Assessment of time to reach maximum concentration derived from serum/plasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
Per dose level (if data permit).
Parts A, B, and D - Assessment of terminal half-life derived from serum/plasma concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
Per dose level (if data permit).
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