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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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