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Brief Title: A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)
Official Title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bemarituzumab Monotherapy and Combination With Other Anti-Cancer Therapy in Subjects With Squamous-Cell Non-Small-Cell Lung Cancer (FORTITUDE-201)
Study ID: NCT05267470
Brief Summary: The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California Irvine, Orange, California, United States
Morristown Medical Center, Morristown, New Jersey, United States
Montefiore Einstein Center for Cancer Care, Bronx, New York, United States
University of Pittsburgh, Cancer Institute, Pittsburgh, Pennsylvania, United States
Cliniques Universitaires Saint Luc, Bruxelles, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, , Belgium
Institut Bergonie, Bordeaux, , France
CHU de Lyon - Hopital Louis Pradel, Bron Cedex, , France
Hôpital Tenon, Paris Cedex 20, , France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie, Poitiers, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou, Rennes, , France
Institut Gustave Roussy, Villejuif, , France
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
Wakayama Medical University Hospital, Wakayama-shi, Wakayama, Japan
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Przychodnia Lekarska Komed Roman Karaszewski, Konin, , Poland
Pratia Mcm Krakow, Krakow, , Poland
Krakowskie Centrum Medyczne Sp zoo, Krakow, , Poland
Instytut Centrum Zdrowia Matki Polki, Lodz, , Poland
Instytut Genetyki i Immunologii GENIM Spzoo, Lublin, , Poland
Centrum Medyczne Hope Clinic Sebastian Szklener, Lublin, , Poland
Mazowieckie centrum leczenia, Otwock, , Poland
Hospital Regional Universitario de Malaga, Malaga, Andalucía, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, Cataluña, Spain
Institut Catala d Oncologia Hospitalet. Hospital Duran i Reynals, Hospitalet de Llobregat, Cataluña, Spain
Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera, A Coruña, Galicia, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation, Taoyuan, , Taiwan
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR