Phase i trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas

Martin Wermke, Enriqueta Felip, Valentina Gambardella, Yasutoshi Kuboki, Daniel Morgensztern, Zohra Oum Hamed, Meiruo Liu, Matus Studeny, Taofeek K. Owonikoko

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)2639-2649
Number of pages11
JournalFuture Oncology
Volume18
Issue number24
DOIs
StatePublished - Aug 2022

Keywords

  • BI 764532
  • DLL3
  • T-cell engager
  • neuroendocrine carcinoma
  • small-cell lung cancer

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