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Brief Title: A Study to Test How Well Different Doses of BI 764532 in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
Official Title: A Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Combined With Ezabenlimab in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
Study ID: NCT05879978
Brief Summary: This study is open to adults with small cell lung cancer and other neuroendocrine tumours that are positive for the tumour marker Delta-like 3 (DLL3). 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 out the highest dose of BI 764532 that people can tolerate when taken together with another medicine called ezabenlimab. BI 764532 and ezabenlimab are antibodies that may help the immune system fight cancer. Participants get BI 764532 and ezabenlimab as infusions into a vein. 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, participants visit the study site about every week. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Brussels - UNIV Saint-Luc, Bruxelles, , Belgium
UNIV UZ Gent, Gent, , Belgium
HOP Louis Pradel, Bron, , France
CTR François Baclesse, Caen, , France
INS Claudius Regaud IUCT-Oncopole, Toulouse, , France
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitätsklinikum Frankfurt, Frankfurt, , Germany
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan