Spots Global Cancer Trial Database for DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
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Trial Identification
Brief Title: DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
Official 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
Study ID: NCT05882058
Study Description
Brief 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-like molecule (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 dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. Participants get BI 764532 infusions 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 over-night stay to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Infirmary Cancer Care, Mobile, Alabama, United States
Mayo Clinic-Arizona, Phoenix, Arizona, United States
Valkyrie Clinical Trials, Los Angeles, California, United States
University of California San Francisco, San Francisco, California, United States
Mayo Clinic Cancer Center, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Indiana University, Indianapolis, Indiana, United States
University of Kentucky Medical Center, Lexington, Kentucky, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Rochester, Minnesota, United States
Montefiore Medical Center, Bronx, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
UNIV UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
MHAT UniHospital, Panagyurishte, , Bulgaria
MHAT Heart and brain, Pleven, , Bulgaria
West China Hospital, Chengdu, , China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, , China
Qilu Hospital, Shangdong University, Jinan, , China
960 Hospital of the Chinese People's Liberation Army, Jinan, , China
The Second Affiliated Hospital to Nanchang University, Nanchang, , China
Shanghai Chest Hospital, Shanghai, , China
HOP Intercommunal, Créteil, , France
HOP Cochin, Paris, , France
HOP Civil, Strasbourg, , France
Evangelische Lungenklinik Berlin, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Asklepios Fachkliniken München-Gauting, Gauting, , Germany
LungenClinic Grosshansdorf GmbH, Großhansdorf, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Aichi Cancer Center Hospital, Aichi, Nagoya, , Japan
National Cancer Center Hospital East, Chiba, Kashiwa, , Japan
Sendai Kousei Hospital, Miyagi, Sendai, , Japan
Kindai University Hospital, Osaka, OsakaSayama, , Japan
Osaka International Cancer Institute, Osaka, Osaka, , Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan
Japanese Foundation for Cancer Research, Tokyo, Koto-ku, , Japan
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital CUF Tejo, Lisboa, , Portugal
Hospital CUF Porto, Porto, , Portugal
Hospital del Mar, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
NCKUH, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital(Linkou), Taoyuan County, , Taiwan
Leicester Royal Infirmary, Leicester, , United Kingdom
University College Hospital, London, , United Kingdom
Freeman Hospital, Newcastle Upon Tyne, , United Kingdom
Contact Details
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