Spots Global Cancer Trial Database for A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
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Trial Identification
Brief Title: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
Official Title: Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations
Study ID: NCT04886804
Interventions
Study Description
Brief Summary: The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Precision NextGen Oncology, Beverly Hills, California, United States
City of Hope, Duarte, California, United States
City of Hope, Huntington Beach, California, United States
City of Hope, Irvine, California, United States
Valkyrie Clinical Trials, Los Angeles, California, United States
University of California Irvine, Orange, California, United States
Georgetown University, Washington, District of Columbia, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Macquarie University, Macquarie Park, New South Wales, Australia
Cabrini Malvern Hospital, Malvern, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen, Linz, , Austria
Brussels - HOSP Jules Bordet, Anderlecht/Brussels-Capital, , Belgium
Beijing Cancer Hospital, Beijing, , China
Jilin Province Cancer Hospital, Changchun, , China
The First Hospital of Jilin University, Changchun, , China
Fujian Cancer Hospital, Fuzhou, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
Harbin Medical University cancer hospital, Haerbin, , China
The First Affiliated Hospital, Zhejiang University, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
The Affiliated Cancer Hospital, Guangxi Medical University, Nanning, , China
Shanghai Chest Hospital, Shanghai, , China
Tianjin Cancer Hospital, Tianjin, , China
Wuhan Union Hospital, Wuhan, , China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T, Wuhan, , China
First Affiliated Hospital of Xiamen University, Xiamen, , China
Henan Cancer Hospital, Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou Unviersity, Zhengzhou, , China
HOP Louis Pradel, Bron, , France
CTR Leon Berard, Lyon, , France
HOP Timone, Marseille, , France
INS Curie, Paris, , France
HOP Pontchaillou, Rennes, , France
INS Gustave Roussy, Villejuif, , France
Universitätsklinikum Augsburg, Augsburg, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Justus-Liebig Universität Gießen, Gießen, , Germany
Universitätsklinikum Köln (AöR), Köln, , Germany
Pius-Hospital, Oldenburg, Oldenburg, , Germany
Prince of Wales Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Rambam Medical Center, Haifa, , Israel
Meir Medical Center, Kfar Saba, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
The Chaim Sheba Medical Center Tel HaShomer, Tel Hashomer, , Israel
Istituto Di Candiolo, Candiolo (TO), , Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale, Napoli, , Italy
Azienda Ospedaliera di Parma, Parma, , Italy
National Cancer Center Hospital East, Chiba, Kashiwa, , Japan
Shikoku Cancer Center, Ehime, Matsuyama, , Japan
Hiroshima University Hospital, Hiroshima, Hiroshima, , Japan
Sendai Kousei Hospital, Miyagi, Sendai, , Japan
Osaka International Cancer Institute, Osaka, Osaka, , Japan
Hamamatsu University Hospital, Shizuoka, Hamamatsu, , Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Nederlands Kanker Instituut, Amsterdam, , Netherlands
Leids Universitair Medisch Centrum (LUMC), Leiden, , Netherlands
Hospital CUF Tejo, Lisboa, , Portugal
Hospital CUF Porto, Porto, , Portugal
National University Hospital, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Karolinska Universitetssjukhuset Solna, Stockholm, , Sweden
The Royal Marsden Hospital, Chelsea, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
The Royal Marsden Hospital, Sutton, Sutton, , United Kingdom
Contact Details
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