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Brief Title: GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors
Official Title: A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors
Study ID: NCT04083599
Brief Summary: To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors.
Detailed Description: This is an open-label, multicenter phase 1/2 study designed to assess the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of GEN1042 administered as a monotherapy or in combination in subjects with metastatic or locally advanced solid tumors.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Cancer & Blood Specialty Clinic, Los Alamitos, California, United States
Moores Cancer Center at the UC San Diego Health, San Diego, California, United States
Yale University Cancer Center, New Haven, Connecticut, United States
ChristianaCare, Newark, Delaware, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Florida Cancer Affiliates, Ocala, Florida, United States
Hope and Healing Cancer Services, Hinsdale, Illinois, United States
University of Kentucky, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Maryland Oncology Hematology PA, Columbia, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Levine Cancer Center, Charlotte, North Carolina, United States
Novant Health Cancer Institute - Forsyth (Medical Oncology), Winston-Salem, North Carolina, United States
Kaiser Permanente (KP) Oncology/Hematology, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Lumi Research, Kingwood, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Virgina Cancer Specialists, Fairfax, Virginia, United States
Adventist Health System/Sunbelt,Inc, Seattle, Washington, United States
Medical Oncology Associates, PS, Spokane, Washington, United States
Rigshospitalet (Copenhagen University Hospital), Copenhagen, , Denmark
Herlev University Hospital, Herlev, , Denmark
University Hospital of Southern Denmark, Vejle Hospital, Vejle, , Denmark
Centre hospitalier Universitaire de Bordeaux, Bordeaux, , France
Centre Antoine Lacassagne, Nice, , France
Gustave Roussy, Villejuif, , France
ARENSIA Research Clinic at the Research Institute of Clinical Medicine, Tbilisi, , Georgia
Nationales Centrum fr Tumorerkrankungen NCT, Heidelberg, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen, , Germany
Department of Dermatology, University of Mainz, Mainz, , Germany
Universitätsmedizin Mannheim Dermatologie, Mannheim, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Rabin Medical Center, Petah tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, , Italy
Azienda Ospedaliera S.Croce e Carle Cuneo, Cuneo, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
Jeonbuk National University Hospital, Jeonju, , Korea, Republic of
Gachon University Gil Medical Center, Namdong, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan, , Korea, Republic of
ARENSIA Research Clinic at the Oncology Institute, Chisinau, , Moldova, Republic of
H. Vall d'Hebron, Barcelona, , Spain
START Barcelona HM Nou Delfos, Barcelona, , Spain
Hospital Duran i Reynals - ICO L Hospitalet, L'Hospitalet De Llobregat, , Spain
Hospital Universitario Insular de Gran Canaria, Las Palmas De Gran Canaria, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
HM CIOCC Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital General Universitario Gregorio Maran, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
START Madrid - Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Complejo Hospitalario Universitario de Santiago (CHUS), Santiago De Compostela, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch, Kaohsiung City, , Taiwan
Kaohsiung Medical University Memorial Hospital, Kaohsiung City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Medical University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, VGHTPE, Taipei, , Taiwan
Chang Gung Memorial Hospital Linkou Branch, Taoyuan, , Taiwan
Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom