Science and Research

DAREON™-5: An open-label, multi-center Phase II dose selection trial of intravenous BI 764532, a DLL3-targeting T cell engager, in patients with relapsed/refractory extensive-stage small cell lung cancer and in patients with other relapsed/refractory neur

The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate. Two different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study has 2 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2, all participants receive the same dose of BI 764532. Part 2 is open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma.

Study details
Study-ID: NCT05882058, 2023 504247 13 00
Study-ID: NCT05882058, 2023 504247 13 00
DZL Disease Area: LC
DZL Disease Area: LC
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL on steering board
DZL Role: DZL on steering board
Funding: Externally - industry
Funding: Externally - industry
DZL Participating Sites: ARCN
DZL Participating Sites: ARCN
Start Date: 13.10.2023
Completion Date: 30.07.2027
Status: Recruiting
Status: Recruiting
DZL on steering board
Link to Study


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