The Second Mitochondria-Derived Activator of Caspases Mimetic BI 891065 in Patients With Advanced Solid Tumors: Results From Two Phase I Studies.

ABSTRACT:

Introduction

BI 891065, a second mitochondria-derived activator of caspases mimetic targets the inhibitor of apoptosis (IAP) family member cIAP1. We describe two first-in-human phase 1 trials assessing BI 891065 ± the anti-programmed cell death protein-1 (PD1) antibody, ezabenlimab, in advanced solid tumors.

Methods

Trials were conducted in the USA (NCT03166631) and Japan (NCT04138823). Dose escalation of BI 891065 monotherapy (part A) and combined with ezabenlimab (part B) was guided by a Bayesian Logistic Regression Model with overdose control. Primary endpoints were maximum tolerated dose (MTD) and number of patients with dose-limiting toxicities (DLTs) in Cycle 1. Other endpoints included objective response (RECIST v 1.1), pharmacokinetics, and changes in peripheral bloo

SUBMITTER: Patel MR 

PROVIDER: S-EPMC12712391 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature