Ezabenlimab (BI 754091), an anti-PD-1 antibody, in patients with advanced solid tumours.

ABSTRACT:

Background

Ezabenlimab (BI 754091) is a humanised monoclonal antibody targeting programmed cell death protein-1. We report results from open-label, dose-escalation/expansion, Phase I trials that evaluated the safety, maximum tolerated dose (MTD), pharmacokinetics and antitumour activity of ezabenlimab at the recommended Phase II dose in patients with selected advanced solid tumours.

Study design

Study 1381.1 (NCT02952248) was conducted in Canada, the United Kingdom and the United States. Study 1381.4 (NCT03433898) was conducted in Japan. Study 1381.3 (NCT03780725) was conducted in the Netherlands. The primary endpoints were: number of patients experiencing dose-limiting toxicities (DLTs) in the first cycle (dose escalation parts), number of patients with DLTs during the enti

SUBMITTER: Patel MR 

PROVIDER: S-EPMC10981579 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature