A Study of Evorpacept (ALX148) in Patients with Advanced HER2+ Gastric Cancer (ASPEN-06)

Last updated: September 5, 2024
Sponsor: ALX Oncology Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Esophageal Disorders

Stomach Cancer

Digestive System Neoplasms

Treatment

Paclitaxel

Trastuzumab

Ramucirumab

Clinical Study ID

NCT05002127
AT148006
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent andfluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line)

  • Adequate Bone Marrow Function.

  • Adequate Renal & Liver Function.

  • Adequate Performance Status

Exclusion

Exclusion Criteria:

  • Patients with known symptomatic CNS metastases or leptomeningeal disease requiringsteroids.

  • Prior treatment with any anti-CD47 or anti-SIRPα agent.

  • Prior treatment with ramucirumab.

Study Design

Total Participants: 450
Treatment Group(s): 4
Primary Treatment: Paclitaxel
Phase: 2/3
Study Start date:
January 15, 2022
Estimated Completion Date:
August 31, 2028

Study 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.

Connect with a study center

  • Icon Cancer Centre Southport

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000
    Belgium

    Active - Recruiting

  • Vseobecna Fakultni Nemocnice v Praze

    Hradec Kralove,
    Czechia

    Site Not Available

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 500 05
    Czechia

    Active - Recruiting

  • Fakultní Nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Fakultní nemocnice Olomouc

    Olomouc,
    Czechia

    Active - Recruiting

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 12800
    Czechia

    Active - Recruiting

  • Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz

    Besançon, 25030
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000
    France

    Active - Recruiting

  • Hôpital Morvan

    Brest, 29200
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69008
    France

    Active - Recruiting

  • Hôpital Privé Jean Mermoz

    Lyon, 69008
    France

    Active - Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009
    France

    Active - Recruiting

  • Hôpital Saint-Antoine

    Paris, 75012
    France

    Active - Recruiting

  • Hôpital Trousseau

    Paris, 75012
    France

    Active - Recruiting

  • Hôpital Rangueil

    Toulouse, 31059
    France

    Active - Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

    Catania, 95123
    Italy

    Active - Recruiting

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134
    Italy

    Active - Recruiting

  • Fondazione IRCCS - Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Active - Recruiting

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128
    Italy

    Active - Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia

    Udine, 33100
    Italy

    Active - Recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577
    Japan

    Active - Recruiting

  • Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • Gifu University Hospital

    Gifu, 501-1194
    Japan

    Active - Recruiting

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • Nagasaki University Hospital

    Nagasaki, 852-8501
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osaka, 589-8511
    Japan

    Active - Recruiting

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Saitama Cancer Center

    Saitama, 362-0806
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, 980-8574
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Shizuoka, 411-8777
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama, 241-8515
    Japan

    Active - Recruiting

  • Oita University Hospital - Hasama Campus

    Ōita, 879-5593
    Japan

    Active - Recruiting

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Active - Recruiting

  • Hallym University Sacred Heart Hospital

    Dongan, 14068
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center - Korea

    Goyang-si, 10408
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju, 561-712
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

    Seoul, 03181
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 02708
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul, 10408
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 06273
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Saint Vincent's Hospital

    Suwon, 16247
    Korea, Republic of

    Active - Recruiting

  • Icon Cancer Centre Farrer Park

    Singapore, 217562
    Singapore

    Active - Recruiting

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Active - Recruiting

  • Hospital General Universitario de Elche

    Alicante, 03203
    Spain

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Quirónsalud Barcelona

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center

    Beitou, 112
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Chi Mei Hospital - Liouying

    Tainan, 73657
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

  • The Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • The Oncology Institute of Hope & Innovation

    Anaheim, California 92801
    United States

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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