1LBA Late Breaking - A Phase I trial of BI 1810631, a HER2 tyrosine kinase inhibitor (TKI), as monotherapy in patients (pts) with advanced/metastatic solid tumors with HER2 aberrations

Abstract

Background: There is an unmet need for effective TKIs against HER2 mutations in solid tumors, particularly in NSCLC. BI 1810631 is a HER2 selective TKI that covalently binds to both wild-type and mutated HER2 receptors, including exon 20 insertions, whilst sparing EGFR signaling; preclinical data suggest good tolerability and efficacy. This Phase Ia/Ib, open-label, non-randomized study aims to determine the safety, MTD, PK, pharmacodynamics and preliminary efficacy of BI 1810631 in pts with HER2 aberration-positive solid tumors (NCT04886804).