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Brief Title: A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Official Title: A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)
Study ID: NCT05325866
Brief Summary: The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
University of California Irvine, Orange, California, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
US Oncology Regulatory Affairs Corporate Office, Denver, Colorado, United States
US Oncology Research Investigational Products Center, Denver, Colorado, United States
Community Health Network MD Anderson Cancer Center - North, Indianapolis, Indiana, United States
Henry Ford Hospital, Detroit, Michigan, United States
Texas Oncology - Dallas Fort Worth, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology Northeast Texas, Tyler, Texas, United States
Instituto Alexander Fleming, Capital Federal, Buenos Aires, Argentina
Hospital Aleman, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Fundacion Cenit Para La Investigacion, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de La Plata, La Plata, Buenos Aires, Argentina
Sociedad de Beneficencia Hospital Italiano, Cordoba, Córdoba, Argentina
Fundacion Medica de Rio Negro y Neuquen, Cipolletti, Río Negro, Argentina
Centro Oncologico Korben, Buenos Aires, , Argentina
Liverpool Hospital, Liverpool, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Wollongong Hospital, Wollongong, New South Wales, Australia
Toowoomba Hospital, Toowoomba, Queensland, Australia
Cabrini Hospital, Malvern, Victoria, Australia
St John of God Murdoch Hospital, Murdoch, Western Australia, Australia
Medizinische Universitaet Graz, Graz, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven, , Belgium
Hospital das Clinicas da Ufmg, Belo Horizonte, Minas Gerais, Brazil
Centro de Oncologia Mackenzie, Curitiba, Paraná, Brazil
Associacao Hospitalar Moinhos de Vento, Porto Alegre, Rio Grande Do Sul, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho, Sao Paulo, São Paulo, Brazil
Beneficencia Portuguesa de Sao Paulo, Sao Paulo, São Paulo, Brazil
Oncologia Rede D Or, Sao Paulo, São Paulo, Brazil
Oncoclinicas Rio de Janeiro S A, Rio de Janeiro, , Brazil
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD, Plovdiv, , Bulgaria
Complex Oncology Center Plovdiv EOOD, Plovdiv, , Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia, Sofia, , Bulgaria
Cross Cancer Institute, Edmonton, Alberta, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Rigshospitalet, Kobenhavn O, , Denmark
Docrates Syopasairaala, Helsinki, , Finland
Tampere University Hospital, Tampere, , Finland
Institut de Cancerologie de l Ouest Rene Gauducheau, Angers Cedex 02, , France
Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz, Besancon cedex, , France
Centre Oscar Lambret, Lille Cedex, , France
Institut Paoli Calmettes, Marseille Cedex 09, , France
Institut regional du Cancer Montpellier, Montpellier Cedex 5, , France
Centre Hospitalier Lyon Sud, Pierre-Benite, , France
Institut Claudius Regaud, Toulouse cedex 9, , France
Gustave Roussy, Villejuif, , France
Sotiria General Hospital, Athens, , Greece
Alexandra Hospital, Athens, , Greece
Metropolitan General, Athens, , Greece
University Hospital of Heraklion, Heraklion - Crete, , Greece
European Interbalkan Medical Center, Thessaloniki, , Greece
Semmelweis Egyetem, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz, Nyiregyhaza, , Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
Rambam Medical Center, Haifa, , Israel
Hadassah Ein-Kerem Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, Foggia, , Italy
Azienda Unità Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano, Mirano, , Italy
Ospedale del Mare, Napoli, , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
Aichi Cancer Center, Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
Kindai University Hospital, Osakasayama-shi, Osaka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Investigación Onco Farmacéutica S de RL de CV, La Paz, Baja California Sur, Mexico
Centro de Infusion e Investigacion Oncologia de Saltillo, Saltillo, Coahuila, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos, Ciudad de Mexico, Distrito Federal, Mexico
Health Pharma Professional Research SA de CV, Mexico City, Distrito Federal, Mexico
Christus Muguerza Clinica Vidriera, Monterrey, Nuevo León, Mexico
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Radboud Universitair Medisch Centrum, Nijmegen, , Netherlands
Pratia Mcm Krakow, Krakow, , Poland
Instytut Centrum Zdrowia Matki Polki, Lodz, , Poland
Ars Medical Spzoo, Pila, , Poland
Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo, Siedlce, , Poland
Centrum Medyczne Pratia Poznan, Skorzewo, , Poland
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier, Lisboa, , Portugal
Hospital da Luz, SA, Lisboa, , Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria, Lisboa, , Portugal
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Cluj Napoca, , Romania
Centrul de Oncologie Sf Nectarie SRL, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
SC Oncomed SRL, Timisoara, , Romania
Hospital Clinico Universitario Virgen de la Victoria, Malaga, Andalucía, Spain
Hospital Clinico Universitario de Santiago, Santiago de Compostela, Galicia, Spain
Kantonsspital Graubuenden, Chur, , Switzerland
Hopitaux Universitaires de Geneve, Geneve, , Switzerland
Christie Hospital, Manchester, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR