BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors

第1/2相 早期終了 NCT04455620

概要

This was an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic and pharmacodynamic (PD) study of BNT151 with expansion cohorts in various solid tumor indications. The study was planned to be performed in Part 1, Part 2A, and Part 2B with adaptive design elements. Part 2 was not conducted because of the clinical study being terminated early. The monotherapy dose escalation, (Part 1) of this clinical study enrolled participants with various solid tumors that are metastatic or of advanced unresectable stage for whom there was no available standard therapy likely to confer clinical benefit, or participants who are not candidates for such available therapy. Dose escalation followed an accelerated titration design, i.e., started with single participant cohorts followed by larger participant cohorts informed by the 3+3 design. Part 1 of the study also planed to implement a dedicated biomarker cohort in BNT151 monotherapy. The biomarker cohort was planned to recruit participants at selected sites in the United States (US) only. The objective of the cohort was to observe PD activity and drug-induced changes in the blood and tumor and only to generate data for explo

Number of Participants With Dose Limiting Toxicities (DLTs) During the DLT Evaluation Period in Part 1

From first dose of IMP up to 21 days (Cycle 1). · participants

Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship

From first dose of IMP through study completion, a maximum of 30 months. · Participants

Number of Paticipants With at Least One TEAE Leading to Dose Reduction, Dose Interruption, and Treatment Discontinuation of BNT151

From first dose of IMP through treatment completion, a maximum of 24 months. · Participants

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