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Study identifier: NCT05882058 Synced from ClinicalTrials.gov · July 29, 2026
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DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

Condition: Small Cell Lung Carcinoma · Neuroendocrine Neoplasms · Extra-pulmonary Neuroendocrine Carcinoma  ·  Sponsor: Boehringer Ingelheim

PhasePhase 2
Planned participants204
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 (also called obrixtamig) that people with advanced cancer can tolerate. 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-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study has 3 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 and Part 3, all participants receive the same dose of BI 764532. Part 2 and Part 3 are open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma. All participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwa…

This description comes directly from the study's public registry record.

Talk to the study team

Boehringer Ingelheim  ·  1-800-243-0127  ·  clintriage.rdg@boehringer-ingelheim.com

Always discuss trial participation with your own doctor first.

Locations (59)

Infirmary Cancer CareMobile, Alabama, United StatesRecruiting
Mayo Clinic-ArizonaPhoenix, Arizona, United StatesRecruiting
Valkyrie Clinical TrialsLos Angeles, California, United StatesRecruiting
University of California San FranciscoSan Francisco, California, United StatesRecruiting
Mayo Clinic Cancer CenterJacksonville, Florida, United StatesRecruiting
University of MiamiMiami, Florida, United StatesRecruiting
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida, United StatesRecruiting
Indiana UniversityIndianapolis, Indiana, United StatesCompleted
University of Kansas Cancer CenterWestwood, Kansas, United StatesCompleted
University of Kentucky Medical CenterLexington, Kentucky, United StatesRecruiting
University of Maryland School of MedicineBaltimore, Maryland, United StatesRecruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesCompleted

+ 47 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05882058