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

August 5, 2025 updated by: ALX Oncology Inc.

A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized phase 2 (open-label) / 3 (blinded), 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.

The Sponsor has decided not to proceed with the Phase 3 portion of the study due to strategic considerations.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • ICON Cancer Centre Southport
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
  • Belgium
      • Antwerp, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc
      • Prague, Czechia, 12800
        • Vseobecna Fakultni nemocnice v Praze
  • France
      • Besançon, France, 25030
        • Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
      • Bordeaux, France, 33000
        • Centre hospitalier universitaire de Bordeaux
      • Brest, France, 29200
        • Hopital Morvan
      • Lyon, France, 69008
        • Centre Leon Berard
      • Lyon, France, 69008
        • Hopital Prive Jean Mermoz
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Paris, France, 75012
        • Hôpital Saint-Antoine
      • Paris, France, 75012
        • Hôpital Trousseau
      • Toulouse, France, 31059
        • Hôpital Rangueil
  • Italy
      • Catania, Italy, 95123
        • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
      • Florence, Italy, 50134
        • Azienda Ospedaliero - Universitaria Careggi
      • Milano, Italy, 20133
        • Fondazione IRCCS - Istituto Nazionale dei Tumori
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
  • Japan
      • Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
      • Fukuoka, Japan, 811-1395
        • Kyushu Cancer Center
      • Gifu, Japan, 501-1194
        • Gifu University Hospital
      • Kumamoto, Japan, 861-8520
        • Japanese Red Cross Kumamoto Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Osaka, Japan, 541-8567
        • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Sendai, Japan, 980-8574
        • Tohoku University Hospital
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of JFCR
      • Yokohama, Japan, 241-8515
        • Kanagawa Cancer Center
      • Ōita, Japan, 879-5593
        • Oita University Hospital - Hasama Campus
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Dongan, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center - Korea
      • Jeonju, Korea, Republic of, 561-712
        • Jeonbuk National University Hospital
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 07061
        • Boramae Medical Center
      • Seoul, Korea, Republic of, 02708
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
      • Seoul, Korea, Republic of, 06273
        • Severance Hospital
      • Seoul, Korea, Republic of, 10408
        • Korea University Guro Hospital
      • Suwon, Korea, Republic of, 16247
        • The Catholic University of Korea Saint Vincent's Hospital
  • Singapore
      • Singapore, Singapore, 217562
        • Icon Cancer Centre Farrer Park
      • Singapore, Singapore, 168583
        • National Cancer Centre Singapore
  • Spain
      • Alicante, Spain, 03203
        • Hospital General Universitario de Elche
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08035
        • Hospital Quironsalud Barcelona
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Taiwan
      • Beitou, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 73657
        • Chi Mei Hospital - Liouying
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and Saint Thomas' NHS Foundation Trust
  • United States
    • California
      • Anaheim, California, United States, 92801
        • The Oncology Institute of Hope & Innovation
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 central nervous system (CNS) metastases or leptomeningeal disease requiring steroids.
  • Prior treatment with any anti-CD47 or anti-SIRPα agent.
  • Prior treatment with ramucirumab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Phase 2 - Arm B
Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Drug: Trastuzumab
IV Q2W
Other Names:
  • Herceptin
Drug: Ramucirumab
IV Q2W
Other Names:
  • Cyramza
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
  • Taxol
Experimental: Phase 3 - Arm A
Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Drug: Evorpacept (ALX148)
IV Q2W
Drug: Trastuzumab
IV Q2W
Other Names:
  • Herceptin
Drug: Ramucirumab
IV Q2W
Other Names:
  • Cyramza
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
  • Taxol
Active Comparator: Phase 3 - Arm B
Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Drug: Ramucirumab
IV Q2W
Other Names:
  • Cyramza
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
  • Taxol
Experimental: Phase 2 - Arm A
Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (IV), trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Drug: Evorpacept (ALX148)
IV Q2W
Drug: Trastuzumab
IV Q2W
Other Names:
  • Herceptin
Drug: Ramucirumab
IV Q2W
Other Names:
  • Cyramza
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 2
Time Frame: Last randomized patient on study at least 16 weeks
Percentage of patients with objective response per RECIST 1.1
Last randomized patient on study at least 16 weeks
Phase 3
Time Frame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose
Overall Survival
From the date of randomization to the date of death (due to any cause), up to 36 months postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALX Oncology Inc.

Collaborators

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Actual)

May 24, 2024

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT148006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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