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Brief Title: A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)
Official Title: A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
Study ID: NCT05002127
Brief Summary: A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.
Detailed Description: This is a randomized phase 2 (open-label) / 3 (double-blind), international, multi-center study of patients with metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy (2nd-line or 3rd-line). Approximately 450 adult patients are expected to be enrolled in the study across both phases.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Oncology Institute of Hope & Innovation, Anaheim, California, United States
University of California Los Angeles, Los Angeles, California, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
NEXT Virginia, Fairfax, Virginia, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Universitair Ziekenhuis Antwerpen, Antwerp, , Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven, , Belgium
Centre Hospitalier Universitaire de Liège, Liège, , Belgium
Vseobecna Fakultni Nemocnice v Praze, Hradec Kralove, , Czechia
Fakultní Nemocnice Hradec Králové, Hradec Králové, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz, Besançon, , France
Centre Hospitalier Universitaire de Bordeaux, Bordeaux, , France
Centre Léon Bérard, Lyon, , France
Hôpital Saint-Antoine, Paris, , France
Hôpital Trousseau, Paris, , France
Hôpital Rangueil, Toulouse, , France
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi, Catania, , Italy
Azienda Ospedaliero - Universitaria Careggi, Florence, , Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano, , Italy
Policlinico Universitario Campus Bio-Medico, Roma, , Italy
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia, Udine, , Italy
National Cancer Center Hospital, Tokyo, , Japan
Dong-A University Hospital, Busan, , Korea, Republic of
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Yeungnam University Medical Center, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
National Cancer Center - Korea, Goyang-si, , Korea, Republic of
Jeonbuk National University Hospital, Jeonju, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Boramae Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea Saint Vincent's Hospital, Suwon, , Korea, Republic of
Icon Cancer Centre Farrer Park, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
Hospital General Universitario de Elche, Alicante, , Spain
Hospital Universitari Vall d'Hebrón, Barcelona, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Guy's and Saint Thomas' NHS Foundation Trust, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom