A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) 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.
View Full Description Full 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.
View Eligibility Criteria Eligibility Criteria Inclusion Criteria: HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line) Adequate Bone Marrow Function. Adequate Renal & Liver Function. Adequate Performance Status Exclusion Criteria: Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids. Prior treatment with any anti-CD47 or anti-SIRPα agent. Prior treatment with ramucirumab.
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There are 5 Locations for this study
The Oncology Institute of Hope & Innovation Anaheim California, 92801, United States
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University of California Los Angeles Los Angeles California, 90095, United States
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Vanderbilt University Medical Center Nashville Tennessee, 37232, United States
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NEXT Virginia Fairfax Virginia, 22031, United States
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Fred Hutchinson Cancer Center Seattle Washington, 98109, United States
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Universitair Ziekenhuis Antwerpen Antwerp , , Belgium
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Universitair Ziekenhuis Leuven - Campus Gasthuisberg Leuven , , Belgium
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Centre Hospitalier Universitaire de Liège Liège , , Belgium
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Vseobecna Fakultni Nemocnice v Praze Hradec Kralove , , Czechia
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Fakultní Nemocnice Hradec Králové Hradec Králové , , Czechia
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Fakultní nemocnice Olomouc Olomouc , , Czechia
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Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz Besançon , , France
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Centre Hospitalier Universitaire de Bordeaux Bordeaux , , France
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Hôpital Saint-Antoine Paris , , France
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Hôpital Rangueil Toulouse , , France
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Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi Catania , , Italy
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Azienda Ospedaliero - Universitaria Careggi Florence , , Italy
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Fondazione IRCCS - Istituto Nazionale dei Tumori Milano , , Italy
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Policlinico Universitario Campus Bio-Medico Roma , , Italy
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Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia Udine , , Italy
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National Cancer Center Hospital Tokyo , , Japan
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Dong-A University Hospital Busan , , Korea, Republic of
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Inje University Haeundae Paik Hospital Busan , , Korea, Republic of
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Pusan National University Hospital Busan , , Korea, Republic of
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Yeungnam University Medical Center Daegu , , Korea, Republic of
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Chungnam National University Hospital Daejeon , , Korea, Republic of
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National Cancer Center - Korea Goyang-si , , Korea, Republic of
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Jeonbuk National University Hospital Jeonju , , Korea, Republic of
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Seoul National University Bundang Hospital Seongnam , , Korea, Republic of
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Asan Medical Center Seoul , , Korea, Republic of
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Boramae Medical Center Seoul , , Korea, Republic of
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Gangnam Severance Hospital Seoul , , Korea, Republic of
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Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Seoul , , Korea, Republic of
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Korea University Anam Hospital Seoul , , Korea, Republic of
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Korea University Guro Hospital Seoul , , Korea, Republic of
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Samsung Medical Center Seoul , , Korea, Republic of
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Seoul National University Hospital Seoul , , Korea, Republic of
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Severance Hospital Seoul , , Korea, Republic of
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The Catholic University of Korea Saint Vincent's Hospital Suwon , , Korea, Republic of
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Icon Cancer Centre Farrer Park Singapore , , Singapore
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National Cancer Centre Singapore Singapore , , Singapore
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Hospital General Universitario de Elche Alicante , , Spain
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Hospital Universitari Vall d'Hebrón Barcelona , , Spain
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Hospital Universitario Reina Sofía Córdoba , , Spain
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Hospital Universitario Ramón y Cajal Madrid , , Spain
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Hospital Universitario Marqués de Valdecilla Santander , , Spain
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China Medical University Hospital Taichung , , Taiwan
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National Cheng Kung University Hospital Tainan , , Taiwan
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National Taiwan University Hospital Taipei , , Taiwan
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Taipei Veterans General Hospital Taipei , , Taiwan
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Guy's and Saint Thomas' NHS Foundation Trust London , , United Kingdom
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Royal Free Hospital London , , United Kingdom
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The Royal Marsden Hospital London , , United Kingdom
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