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

M Wermke, E Felip, V Gambardella, Y Kuboki… - Future …, 2022 - Taylor & Francis
M Wermke, E Felip, V Gambardella, Y Kuboki, D Morgensztern, ZO Hamed, M Liu…
Future Oncology, 2022Taylor & Francis
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 …
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.
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