DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
Start Date
10/13/2023
Completion Date
6/8/2028
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 (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 unwanted effects and regularly check the general health of the participants.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BI 764532, dose 1
BI 764532, dose 2
Ventana DLL3 RxDx assay
Conditions
Locations
Infirmary Cancer Care
Mobile, Alabama 36607
United States
Mayo Clinic-Arizona
Phoenix, Arizona 85054
United States
Valkyrie Clinical Trials
Los Angeles, California 90067
United States
University of California San Francisco
San Francisco, California 94143
United States
Mayo Clinic Cancer Center
Jacksonville, Florida 32224
United States
University of Miami
Miami, Florida 33136
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United States
Indiana University
Indianapolis, Indiana 46202
United States
University of Kansas Cancer Center
Westwood, Kansas 66205
United States
University of Kentucky Medical Center
Lexington, Kentucky 40536
United States
University of Maryland School of Medicine
Baltimore, Maryland 21201
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mayo Clinic, Rochester
Rochester, Minnesota 55905
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Montefiore Medical Center
The Bronx, New York 10461
United States
Virginia Commonwealth University Health- Adult Outpatient Pavilion
Richmond, Virginia 23219
United States
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
UZ Leuven
Leuven, 3000
Belgium
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, 4500
Bulgaria
MHAT Heart and brain
Pleven, 5804
Bulgaria
West China Hospital, Sichuan University
Chengdu, 610041
China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
China
Qilu Hospital, Shangdong University
Jinan, 250012
China
960 Hospital of the Chinese People's Liberation Army
Jinan, 250031
China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
China
Shanghai Chest Hospital
Shanghai, 200030
China
HOP Intercommunal
Créteil, 94000
France
Hôpital Cochin
Paris, 75014
France
HOP Civil
Strasbourg, 67091
France
Evangelische Lungenklinik Berlin
Berlin, 13125
Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Germany
Universitätsklinikum Erlangen
Erlangen, 91054
Germany
Asklepios Fachkliniken München-Gauting
Gauting, 82131
Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Germany
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Japan
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Japan
Sendai Kousei Hospital
Miyagi, Sendai, 981-0914
Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Japan
Kindai University Hospital
Osaka, Sakai, 590-0197
Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Japan
Hospital CUF Descobertas-Lisboa-69316
Lisbon, 1350-352
Portugal
Hospital CUF Porto
Porto, 4100-180
Portugal
Severance Hospital
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hospital del Mar
Barcelona, 08003
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
NCKUH
Tainan, 704
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan County, 333
Taiwan
Leicester Royal Infirmary
Leicester, LE1 5WW
United Kingdom
University College Hospital
London, WC1E 6AG
United Kingdom
The Christie Hospital
Manchester, M20 4BX
United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
United Kingdom