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First received: November 21, 2023

Clinical Trial: Safety and Preliminary Efficacy of BNT314 With or Without an Immune Checkpoint Inhibitor in Cancer Patients With Malignant Solid Tumors

Study Status: Completed

Recruit Status: RECRUITING

Condition: Advanced Malignant Solid Tumor

Study Type: INTERVENTIONAL


Official Title: A First-in-Human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 in Monotherapy and in Combination With an Immune Checkpoint Inhibit

Brief Summary: The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone and when it is used together with another antibody cancer drug (pembrolizumab) in patients with different types of cancer.Patients will receive either BNT314 alone or BNT314 combined with pembrolizumab.Phase 1 of the study consists of a dose escalation part, and a safety run-in (SRI) and expansion part:Dose escalation: In this part of the study, patients will be assigned to multiple dose levels (DLs) of BNT314 given…

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