Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Start Date
6/3/2024
Completion Date
1/8/2029
Summary
This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow. In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group. During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Zongertinib
Trastuzumab deruxtecan
Trastuzumab emtansine
Trastuzumab
Capecitabine
mFOLFOX6
zanidatamab
Conditions
Locations
The Oncology Institute of Hope and Innovation
Cerritos, California 90703
United States
Ellison Medical Institute
Los Angeles, California 90064
United States
Valkyrie Clinical Trials
Los Angeles, California 90067
United States
University of California Los Angeles
Los Angeles, California 90095
United States
University of California Irvine
Orange, California 92868
United States
Sharp Memorial Hospital
San Diego, California 92123
United States
Yale University School of Medicine
New Haven, Connecticut 06510
United States
Helios CR Inc
Lakeland, Florida 33812
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United States
Orchard Healthcare Research Inc.- Skokie
Skokie, Illinois 60077
United States
Community Health Network
Indianapolis, Indiana 46250
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
New York Cancer & Blood Specialists
Shirley, New York 11967
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
Baptist Cancer Center - Memphis
Memphis, Tennessee 38120
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Tennessee Oncology, Pllc
Nashville, Tennessee 37203
United States
The Methodist Hospital Research Institute
Houston, Texas 77030
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Belgium
UZ Leuven
Leuven, 3000
Belgium
Hôpital Vivalia De Libramont
Libramont-Chevigny, 6800
Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000
Belgium
CHU UCL Namur
Namur, 5000
Belgium
Jilin Province Cancer Hospital
Changchun, 130012
China
The First Hospital of Jilin University
Changchun, 130021
China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310000
China
Harbin Medical University Cancer Hospital
Harbin, 150081
China
Jiangsu Province Hospital
Nanjing, 210029
China
Fudan University Shanghai Cancer Center
Shanghai, 200032
China
Tianjin Cancer Hospital
Tianjin, 300060
China
Henan Cancer Hospital
Zhengzhou, 450003
China
INS Bergonie
Bordeaux, 33000
France
CTR François Baclesse
Caen, 14076
France
CTR Georges-François Leclerc
Dijon, 21000
France
CTR Leon Berard
Lyon, 69008
France
INS Paoli-Calmettes
Marseille, 13273
France
HOP Tenon
Paris, 75020
France
CTR Eugène Marquis
Rennes, 35042
France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
France
Institut de Cancérologie de Strasbourg
Strasbourg, 67200
France
INS Claudius Regaud IUCT-Oncopole
Toulouse, 31059
France
Institut Gustave Roussy
Villejuif, 94805
France
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Germany
Universitätsklinikum Erlangen
Erlangen, 91054
Germany
Evang. Kliniken Essen-Mitte gGmbh
Essen, 45136
Germany
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, 22763
Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167
Germany
Universitätsklinikum Ulm
Ulm, 89075
Germany
Istituto Di Candiolo
Candiolo (TO), 10060
Italy
Az.Osp. Universitaria "Ospedali Riuniti"
Foggia, 71122
Italy
Istituto Scientifico Romagnolo
Meldola (FC), 47014
Italy
Ospedale San Raffaele S.r.l.
Milan, 20132
Italy
Istituto Europeo di Oncologia
Milan, 20141
Italy
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), 95045
Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131
Italy
Istituto Clinico Humanitas
Rozzano, 20089
Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Japan
Tokai University Hospital
Isehara, 259-1193
Japan
Hakuaikai Sagara Hospital
Kagoshima, 892-0833
Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
Japan
National Cancer Center Hospital East
Kashiwa-shi, 277-8577
Japan
Kyoto University Hospital
Kyoto, 606-8507
Japan
Osaka International Cancer Institute
Osaka, 541-8567
Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Japan
CHA Bundang Medical Center
Seongnam-si, 13496
South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Korea University Anam Hospital
Seoul, 2841
South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 6273
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 6591
South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Spain
Hospital del Mar
Barcelona, 08003
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Clínic de Barcelona
Barcelona, 08036
Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 8906
Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Spain
Clínica Universidad de Navarra - Madrid
Madrid, 28022
Spain
Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Clínico San Carlos
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
CIO Clara Campal
Madrid, 28050
Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009
Spain
Instituto Valenciano de Oncología
Valencia, 46009
Spain
Velindre Cancer Centre
Cardiff, CF14 2TL
United Kingdom
St James's University Hospital
Leeds, LS9 7TF
United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE
United Kingdom
University College Hospital
London, NW1 2BU
United Kingdom
Royal Free Hospital
London, NW3 2QG
United Kingdom
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
United Kingdom
The Christie Hospital
Manchester, M20 4BX
United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
United Kingdom
Nottingham University Hospital
Nottingham, NG5 1PB
United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
United Kingdom