Updated data from a phase I trial of the DLL3/CD3 IgG-like T-cell engager BI 764532 in patients (pts) with DLL3-positive (+) tumors: Focus on extrapulmonary neuroendocrine carcinomas (epNECs)

#4019

Introduction: DLL3 is expressed on several cancers including epNECs. BI 764532 is a DLL3/CD3 IgG-like T-cell engager. NCT04429087 is a Phase I trial of BI 764532 in pts with locally advanced/metastatic DLL3+ small-cell lung cancer, epNEC or large-cell neuroendocrine lung carcinoma. Here we focus on pts with epNEC.

Aim(s): To determine the MTD and/or RDE of BI 764532. Other objectives: safety, tolerability, PK, PD and preliminary efficacy (investigator review; RECIST v1.1).

Materials and methods: BI 764532 was given IV in 4 regimens: Regimen A (RA; fixed dose q3w); RB1 (fixed dose qw); RB2 and RB3 (step-in dose, followed by target dose). Tx continued until PD, unacceptable toxicity, other withdrawal criteria or max Tx duration (36 mos).

Conference:

Presenting Author: Capdevila J

Authors: Capdevila J, Gambardella V, Kuboki Y, Alese O, Morgensztern D,

Keywords: DLL3, NEC, T-cell engager,