Open AccessPhase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas
Author(s) -
Martin Wermke,
Enriqueta Felip,
Valentina Gambardella,
Yasutoshi Kuboki,
Daniel Morgensztern,
Zohra Oum' Hamed,
Meiruo Liu,
Matus Studeny,
Taofeek K. Owonikoko
Publication year - 2022
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2022-0196
Subject(s) - medicine , tolerability , oncology , cell , neuroendocrine tumors , cancer , cancer research , lung cancer , pathology , adverse effect , biology , genetics
Poorly differentiated neuroendocrine carcinomas such as small-cell lung cancer (SCLC) have poor survival and high relapse rates. DLL3 is found on these carcinomas and has become a target of increasing interest in recent years. The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model. Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.