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Brief Title: DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers
Official Title: DAREON™-7: A Phase I, Open-label, Dose Escalation and Expansion Trial to Investigate Safety and Tolerability of BI 764532 Intravenous Infusions in Combination With Standard of Care (Platinum and Etoposide) in First-line Treatment of Patients With Neuroendocrine Carcinomas (NEC)
Study ID: NCT06132113
Brief Summary: This study is open to adults aged 18 and older or above legal age who have a specific type of advanced neuroendocrine cancer (NEC). Their tumours must be positive for a marker called DLL3. The purpose of this study is to test a medicine called BI 764532 in addition to chemotherapy. The study has 2 parts. Part A of this study aims to find out the highest dose of BI 764532 that people can tolerate in addition to chemotherapy. The purpose of Part B is to find out how well people can tolerate BI 764532 in combination with different chemotherapies. Researchers also want to find out whether BI 764532 in combination with chemotherapy helps people with NEC. Participants get different doses of BI 764532 as an infusion into a vein. In addition, they get platinum-based chemotherapy as infusions into a vein. Participants can continue treatment up to 3 years if they benefit from treatment and can tolerate it. Participants visit their doctors regularly. During these visits, the doctors collect information about participants' health and take note of any unwanted effects. Doctors also regularly check the size of the tumour.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northwestern University, Chicago, Illinois, United States
Universitätsklinikum Tübingen, Tübingen, , Germany
Aichi Cancer Center Hospital, Aichi, Nagoya, , Japan
National Cancer Center Hospital East, Chiba, Kashiwa, , Japan
Osaka International Cancer Institute, Osaka, Osaka, , Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital La Paz, Madrid, , Spain