BI 1438-0001 is a multicenter, open-label, Phase I dose-escalation and expansion study investigating the bispecific T-cell engager BI 764532 in DLL3-positive neoplasms. The study enrolls adult patients with small cell lung cancer (SCLC), large cell neuroendocrine lung carcinoma (LCNEC), or extrapulmonary neuroendocrine carcinomas (epNEC) that are locally advanced or metastatic and have progressed after standard therapy. The primary objective is to determine the maximum tolerated dose (MTD) and identify dose-limiting toxicities (DLTs). DLL3 expression is verified via immunohistochemistry during central screening. The investigational product is administered intravenously in escalating doses to evaluate the pharmacokinetic profile and safety. Key secondary endpoints include the objective response rate (ORR) per RECIST 1.1 and duration of response (DOR).
This study tests a new drug called BI 764532 in patients with small cell lung cancer or other neuroendocrine tumors. To participate, the tumor cells must carry a specific protein called DLL3 on their surface. As this is an early-phase research study, the primary goal is to determine which dose of the medication is safe and best tolerated. The drug is administered as an intravenous infusion. Researchers closely monitor whether and to what extent the tumor shrinks during treatment. The aim is to identify an effective dose for the further development of this targeted therapy.
