By Fineline Cube Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct an open, multi-center Phase II dose-setting study. The study will assess the efficacy and safety of BI 764532 in patients with recurrent/refractory extensive-stage small cell lung cancer (ES-SCLC) and other recurrent/refractory neuroendocrine tumors.
BI 764532: A Bispecific Antibody Targeting DLL3 and CD3
BI 764532 is a bispecific antibody (BsAb) that targets delta-like protein 3 (DLL3) and CD3, designed to induce immune-mediated killing of cancer cells expressing DLL3. This innovative approach has shown preliminary efficacy in SCLC and other neuroendocrine tumors, with previous studies indicating an objective response rate (ORR) of 18% and a disease control rate (DCR) of 41%.
Significance of the Phase II Study
The Phase II study represents a significant step in the development of BI 764532, providing a deeper understanding of its potential role in treating ES-SCLC and other neuroendocrine tumors. The open, multi-center design of the study will allow for a comprehensive evaluation of the drug’s efficacy and safety profile, crucial for advancing novel treatment options for patients with these challenging conditions.-Fineline Info & Tech