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

DLL3 is a protein involved in development of the embryo during pregnancy. It has also been found on the surface of cells involved in the development of certain types of lung cancer and other tumors. The T-cell engager BI 764532 binds to DLL3 and cells of the immune system simultaneously, resulting in the death of tumor cells. Here we describe the rationale for, and design of, a clinical study of BI 764532 in patients with small-cell lung cancer and other tumors containing DLL3. The aim of the study is to find the highest acceptable dose of BI 764532 that can be tolerated by patients, and explore the safety and efficacy of BI 764532. Clinical Trial Registration: NCT04429087 (ClinicalTrials.gov).