MS BioNTech WKN: A2PSR2 ISIN: US09075V1026 Forum: Aktien User: Thekla

Pogues Konzerte waren ein Erlebnis! Das er noch so lange lebte, krass. Er sah schon in den 80ern nicht gesund aus ;)

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 Inhibitor in Patients With Advanced Malignant Solid Tumors 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 alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose (MTD) which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose (MAD) will be investigated. At the end of this part, the Recommended Phase 2 Dose (RP2D) which is the dose to be tested in Phase 2 will be decided. Safety Run-In: In this part of the study, BNT314 will be combined with pembrolizumab. Before starting the expansion part, the combination will be tested in another small group of participants (12-28) to find out how safe this combination is. Expansion: In this part of the study, BNT314 will be combined with pembrolizumab. After the SRI is completed, the study will continue with the expansion part where up to 199 participants with different types of cancer will be included. The Phase 2 part of the study will be introduced via an amendment to the study protocol. Start Date 01 Dec 2023

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