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Brief Title: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Official Title: A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer
Study ID: NCT05498428
Brief Summary: The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California at San Diego, La Jolla, California, United States
University of California Irvine, Orange, California, United States
Stanford Cancer Institute, Stanford, California, United States
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital, Washington, District of Columbia, United States
Baptist Lynn Cancer Institute, Boca Raton, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
AdventHealth, Orlando, Florida, United States
H. Lee Moffitt Cancer & Research Institute, Tampa, Florida, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Boston Medical Center, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Hemotology Oncology Associates of CNY, East Syracuse, New York, United States
Novant Health, Charlotte, North Carolina, United States
Novant Health, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Cleveland Clinic, Mayfield Heights, Ohio, United States
Cleveland Clinic, Warrensville Heights, Ohio, United States
The Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
Fundacao Pio XII, Barretos, , Brazil
PERSONAL Oncologia de Precisao e Personalizada, Belo Horizonte, , Brazil
Instituto do Cancer de Londrina - Hospital do Cancer de Londrina, Londrina, , Brazil
Associacao Hospitalar Moinhos de Vento, Porto Alegre, , Brazil
Instituto D Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, , Brazil
Instituto D Or de Pesquisa e Ensino (IDOR), Salvador, , Brazil
Hospital Alemao Oswaldo Cruz, Sao Paulo, , Brazil
Impar Servicos Hospitalares SA - Hospital Nove de Julho, Sao Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center, Sao Paulo, , Brazil
Affiliated Hospital of Hebei University, Baoding, , China
Jilin cancer hospital, Changchun, , China
Sichuan Cancer Hospital, Chengdu, , China
West China Hospital Sichuan University, Chengdu, , China
The First Affiliated Hospital of PLA Army Medical University, ChongQing, , China
The First Affiliated Hospital Sun Yat sen University, Guangzhou, , China
The First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, , China
Harbin medical university cancer hospital, Harbin, , China
Huizhou Municipal Central Hospital, Huizhou, , China
Liuzhou people's Hospital, Liuzhou, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Tianjin Medical University General Hospital, Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, , China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology, Wuhan, , China
Hospital of Jiangnan University, Wuxi, , China
The First Affiliated Hospital of Xian Jiaotong University, XI An, , China
Yantai Yuhuangding Hospital, Yantai, , China
Centre Francois Baclesse, Caen Cedex 05, , France
Centre Georges-François Leclerc, Dijon, , France
Institut de Cancérologie du Gard, Nîmes, , France
Institut Curie, PARIS Cedex 5, , France
Institut de cancerologie de l'ouest, Saint-Herblain Cedex, , France
Gustave Roussy, Villejuif Cedex, , France
Evangelische Lungenklinik Berlin, Berlin, , Germany
LungenClinic Grosshansdorf GmbH, Grosshandorf, , Germany
Lungenfachklinik Immenhausen, Immenhausen, , Germany
Universitaetsklinikum Koelnt, Koeln, , Germany
Klinikum Würzburg Mitte gGmbH Standort Missioklinik, Wuerzburg, , Germany
Rambam Medical Center Department of Pediatric Pulmonology Meyer Childern's Hospital, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Policlinico Hospital San Martino- IRCCS for Oncology, Genova, , Italy
Ospedale San Raffaele, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliera San Gerardo, Monza, , Italy
Azienda Ospedaliera Specialistica dei Colli, Naples, , Italy
National Hospital Organization Himeji Medical Center, Himeji, , Japan
Matsusaka Municipal Hospital, Matsusaka, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Wakayama Medical University Hospital, Wakayama, , Japan
National Cancer Center, Goyang-Si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan, Kuantan, , Malaysia
Hospital Umum Sarawak, Kuching, , Malaysia
Beacon Hospital Sdn Bhd, Petaling Jaya, , Malaysia
Hosp. Univ. A Coruna, A Coruña, , Spain
General University Hospital of Alicantet, Alacant, , Spain
Hosp. Del Mar, Barcelona, , Spain
Hosp. de La Santa Creu I Sant Pau, Barcelona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals, Barcelona, , Spain
Hosp. Gral. Univ. Gregorio Maranon, Madrid, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. La Paz, Madrid, , Spain
Hosp. Regional Univ. de Malaga, Malaga, , Spain
Hosp. Virgen Macarena, Sevilla, , Spain
Hosp. Clinico Univ. de Valencia, Valencia, , Spain
Hosp. Gral. Univ. Valencia, Valencia, , Spain
Cheltenham General Hospital, Cheltenham, , United Kingdom
Torbay Hospital-Devon, Devon, , United Kingdom
Edinburgh Cancer Centre Western General, Edinburgh, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
University College London Hospitals, London, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Queen Alexandra Hospital, Portsmouth, , United Kingdom
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR