Esophageal Cancer Clinical Trial

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.

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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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

450

Study ID:

NCT05002127

Recruitment Status:

Recruiting

Sponsor:

ALX Oncology Inc.

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There are 5 Locations for this study

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The Oncology Institute of Hope & Innovation
Anaheim California, 92801, United States More Info
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University of California Los Angeles
Los Angeles California, 90095, United States More Info
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Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
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NEXT Virginia
Fairfax Virginia, 22031, United States More Info
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Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States More Info
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Universitair Ziekenhuis Antwerpen
Antwerp , , Belgium More Info
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Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven , , Belgium More Info
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Centre Hospitalier Universitaire de Liège
Liège , , Belgium More Info
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Vseobecna Fakultni Nemocnice v Praze
Hradec Kralove , , Czechia More Info
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Fakultní Nemocnice Hradec Králové
Hradec Králové , , Czechia More Info
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Fakultní nemocnice Olomouc
Olomouc , , Czechia More Info
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Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
Besançon , , France More Info
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Centre Hospitalier Universitaire de Bordeaux
Bordeaux , , France More Info
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Centre Léon Bérard
Lyon , , France More Info
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Hôpital Saint-Antoine
Paris , , France More Info
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Hôpital Trousseau
Paris , , France More Info
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Hôpital Rangueil
Toulouse , , France More Info
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Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
Catania , , Italy More Info
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Azienda Ospedaliero - Universitaria Careggi
Florence , , Italy More Info
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Fondazione IRCCS - Istituto Nazionale dei Tumori
Milano , , Italy More Info
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Policlinico Universitario Campus Bio-Medico
Roma , , Italy More Info
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Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
Udine , , Italy More Info
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National Cancer Center Hospital
Tokyo , , Japan More Info
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Dong-A University Hospital
Busan , , Korea, Republic of More Info
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Inje University Haeundae Paik Hospital
Busan , , Korea, Republic of More Info
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Pusan National University Hospital
Busan , , Korea, Republic of More Info
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Yeungnam University Medical Center
Daegu , , Korea, Republic of More Info
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Chungnam National University Hospital
Daejeon , , Korea, Republic of More Info
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National Cancer Center - Korea
Goyang-si , , Korea, Republic of More Info
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Jeonbuk National University Hospital
Jeonju , , Korea, Republic of More Info
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Seoul National University Bundang Hospital
Seongnam , , Korea, Republic of More Info
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Asan Medical Center
Seoul , , Korea, Republic of More Info
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Boramae Medical Center
Seoul , , Korea, Republic of More Info
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Gangnam Severance Hospital
Seoul , , Korea, Republic of More Info
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Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul , , Korea, Republic of More Info
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Korea University Anam Hospital
Seoul , , Korea, Republic of More Info
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Korea University Guro Hospital
Seoul , , Korea, Republic of More Info
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Samsung Medical Center
Seoul , , Korea, Republic of More Info
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Seoul National University Hospital
Seoul , , Korea, Republic of More Info
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Severance Hospital
Seoul , , Korea, Republic of More Info
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The Catholic University of Korea Saint Vincent's Hospital
Suwon , , Korea, Republic of More Info
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Icon Cancer Centre Farrer Park
Singapore , , Singapore More Info
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National Cancer Centre Singapore
Singapore , , Singapore More Info
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Hospital General Universitario de Elche
Alicante , , Spain More Info
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Hospital Universitari Vall d'Hebrón
Barcelona , , Spain More Info
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Hospital Universitario Reina Sofía
Córdoba , , Spain More Info
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Hospital Universitario Ramón y Cajal
Madrid , , Spain More Info
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Hospital Universitario Marqués de Valdecilla
Santander , , Spain More Info
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China Medical University Hospital
Taichung , , Taiwan More Info
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National Cheng Kung University Hospital
Tainan , , Taiwan More Info
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National Taiwan University Hospital
Taipei , , Taiwan More Info
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Taipei Veterans General Hospital
Taipei , , Taiwan More Info
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Guy's and Saint Thomas' NHS Foundation Trust
London , , United Kingdom More Info
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Royal Free Hospital
London , , United Kingdom More Info
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The Royal Marsden Hospital
London , , United Kingdom More Info
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How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

450

Study ID:

NCT05002127

Recruitment Status:

Recruiting

Sponsor:


ALX Oncology Inc.

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