Phase IIIa Study to Evaluate Safety and Early Effectiveness of BNT3214 Given by IV Infusion in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating BNT3214, also known as PM8102, in adults with advanced solid tumors in this early-phase clinical trial. The study aims to determine the safety and initial effectiveness of BNT3214, marking its first testing in people. The trial consists of three parts Parts A and B focus on finding the safest and best dose levels, while Part C tests selected doses in various types of cancer. An internal review committee oversees safety and dosing decisions throughout the study. Participants receive intravenous infusions of BNT3214 in varying dose levels. Parts A and B explore dose escalation and alternative dosing schedules to identify optimal dosing. Part C includes dose optimization and expansion cohorts without randomization in most parts, except for dose optimization cohorts where participants may be randomized between two dose levels. Treatment continues up to two years or until disease progression, unacceptable side effects, or other stopping criteria. During the study, participants undergo regular safety and response assessments, including monitoring for side effects, dose adjustments, and evaluation of tumor response based on standard criteria. Blood samples will be collected for pharmacokinetic and antibody testing. Researchers will measure outcomes such as treatment-emergent adverse events, dose-limiting toxicities, and objective response rates over up to 30 months. The study includes thorough safety monitoring until 90 days after the last dose, with participants followed for up to two years or until other study-defined endpoints occur.

Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors