1438-0005: A dose selection trial of intravenous BI 764532
Research type
Research Study
Full title
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 neuroendocrine carcinomas
IRAS ID
1007923
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Clinicaltrials.gov Identifier
Research summary
This study is open to adults with small cell lung cancer and other neuroendocrine tumours.
The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.
The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone. 2 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 (DLL3/CD3 bispecific) that may help the immune system fight cancer.
Participants are put into 2 groups randomly, which means by chance. One group gets a lower dose of BI 764532 and the other group gets a higher dose of BI 764532. Participants get BI 764532 infusions once per week for the first 6 weeks and then once every 3 weeks. If
there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, they visit the study site regularly. For the first 4 visits, the participants remain at the study site for at least 1 night. Doctors regularly check the size
of the tumour and whether it has spread to other parts of the body. Doctors record any unwanted effects and regularly check the general health of the participants.REC name
North West - Haydock Research Ethics Committee
REC reference
23/NW/0218
Date of REC Opinion
10 Nov 2023
REC opinion
Further Information Favourable Opinion