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Brief Title: A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
Official Title: A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers
Study ID: NCT04466891
Brief Summary: This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
University of California Los Angeles, Santa Monica, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
Advent Health Cancer Institute, Orlando, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Texas Southwestern Medical Center - Hospital, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Princess Margaret Hospital, Toronto, Ontario, Canada
Centro de Cáncer Nuestra Señora de la Esperanza, Santiago, , Chile
Radiomed (Clinica Alemana de Temuco), Temuco, , Chile
Beijing Cancer Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
West China Hospital, Chengdu, , China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, , China
The First Affiliated Hospital of Zhejiang University, Hangzhou, , China
Zhejiang Provincial People's Hospital, Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Affiliated Tumor Hospital of Harbin Medical University, Harbin, , China
Anhui Provincial Hospital, Hefei, , China
Huzhou Central Hospital, Huzhou, , China
Jinhua Central Hospital, Jinhua, , China
The First Hospital Of Lanzhou University, Lanzhou, , China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, , China
Shandong Provincial Third Hospital, Shandong, , China
Affiliated Zhongshan Hospital of Fudan University, Shanghai, , China
The Third Affiliated Hospital of the Chinese PLA, Shanghai, , China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
Weifang People's Hospital, Weifang, , China
Hubei Cancer Hospital, Wuhan, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Oncologie médicale Hopital Jean Minjoz, Besançon, , France
Institut de Cancerologie et d'Hematologie Hopital Morvan - CHRU de Brest, Brest, , France
Hopitaux de La Timone, Marseille, , France
Département Oncologie Gastro-entérologie CHRU de Poitiers La Miletrie, Poitiers, , France
Département De Médecine, Villejuif, , France
Fondazione del Piemonte per l'Oncologia (IRCCS), Candiolo, , Italy
Istituto Nazionale Dei Tumori, Milano, , Italy
Istituto Clinico Humanitas, Milan, , Italy
Istituto Oncologico Veneto - I.R.C.C.S., Padova, , Italy
Gyeongsang National University Hospital, Jinju-si, , Korea, Republic of
Pusan National University Hospital, Pusan, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Universitario Germans Trias i Pujol, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Doce de Octubre, Madrid, , Spain
Corporacio Sanitaria Parc Tauli, Sabadell, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
University College London Hospitals (UCLH), London, , United Kingdom
Royal Free London NHS Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom