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Gastric CancerPhase 2/3NCT05002127

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

A Phase 2/3 study testing Evorpacept (ALX148), Trastuzumab and Ramucirumab in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by ALX Oncology Inc. at 83 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Evorpacept (ALX148), Trastuzumab and Ramucirumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
83 sitesin 12 countries
Study dates
15 Jan 2022to 30 Jun 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

83 sites in 12 countries.

83 sites in 12 countries

South Korea19 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Yeungnam University Medical Center

    Daegu, 42415

  • Chungnam National University Hospital

    Daejeon, 35015

  • Hallym University Sacred Heart Hospital

    Dongan, 14068

  • National Cancer Center - Korea

    Goyang-si, 10408

  • Jeonbuk National University Hospital

    Jeonju, 561-712

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Korea University Anam Hospital

    Seoul, 02708

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

    Seoul, 03181

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Boramae Medical Center

    Seoul, 07061

  • Korea University Guro Hospital

    Seoul, 10408

  • The Catholic University of Korea Saint Vincent's Hospital

    Suwon, 16247

Other trials in South Korea

Japan15 sites

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Kyushu Cancer Center

    Fukuoka, 811-1395

  • Gifu University Hospital

    Gifu, 501-1194

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Oita University Hospital - Hasama Campus

    Ōita, 879-5593

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka, 541-8567

  • Kindai University Hospital

    Osaka, 589-8511

  • Saitama Cancer Center

    Saitama, 362-0806

  • Tohoku University Hospital

    Sendai, 980-8574

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Kanagawa Cancer Center

    Yokohama, 241-8515

Other trials in Japan

Spain10 sites

  • Hospital General Universitario de Elche

    Alicante, 03203

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Quirónsalud Barcelona

    Barcelona, 08035

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

France9 sites

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

    Besançon, 25030

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000

  • Hôpital Morvan

    Brest, 29200

  • Centre Léon Bérard

    Lyon, 69008

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

  • Institut Paoli-Calmettes

    Marseille, 13009

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital Trousseau

    Paris, 75012

  • Hôpital Rangueil

    Toulouse, 31059

Other trials in France

Taiwan7 sites

  • Koo Foundation Sun Yat-Sen Cancer Center

    Beitou, 112

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Hospital - Liouying

    Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 10048

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

United States5 sites

  • The Oncology Institute of Hope & Innovation

    Anaheim, California, 92801

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

Other trials in United States

Italy5 sites

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

    Catania, 95123

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134

  • Fondazione IRCCS - Istituto Nazionale dei Tumori

    Milan, 20133

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

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

    Udine, 33100

Other trials in Italy

Belgium3 sites

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

Czechia3 sites

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultní Nemocnice Olomouc

    Olomouc, 779 00

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 12800

Other trials in Czechia

United Kingdom3 sites

  • Royal Free Hospital

    London, NW3 2QG

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, SE1 9RT

  • The Royal Marsden Hospital

    London, SW3 6JJ

Other trials in United Kingdom

Australia2 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Icon Cancer Centre Southport

    Southport, Queensland, 4215

Other trials in Australia

Singapore2 sites

  • National Cancer Centre Singapore

    Singapore, 168583

  • Icon Cancer Centre Farrer Park

    Singapore, 217562

Other trials in Singapore

About this study

Official title: 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.

Read the 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.

Being tested
Evorpacept (ALX148), Trastuzumab, Ramucirumab, Paclitaxel
Keywords
ALX148, CD47, SIRPα, Gastric, Gastroesophageal, GEJ, HER2 positive, Ramucirumab, Evorpacept
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evorpacept (ALX148)Drug

    IV Q2W

  • TrastuzumabDrug

    Also called Herceptin

    IV Q2W

  • RamucirumabDrug

    Also called Cyramza

    IV Q2W

  • PaclitaxelDrug

    Also called Taxol

    IV Days 1, 8, and 15 of a 28-day cycle

Study groups in NCT05002127
Study groupRoleWhat they receive
Phase 2 - Arm AExperimentalEvorpacept (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.
Receives: Drug: Evorpacept (ALX148); Drug: Trastuzumab; Drug: Ramucirumab; Drug: Paclitaxel
Phase 2 - Arm BActive comparatorTrastuzumab (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.
Receives: Drug: Trastuzumab; Drug: Ramucirumab; Drug: Paclitaxel
Phase 3 - Arm AExperimentalEvorpacept (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.
Receives: Drug: Evorpacept (ALX148); Drug: Trastuzumab; Drug: Ramucirumab; Drug: Paclitaxel
Phase 3 - Arm BActive comparatorRamucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Receives: Drug: Ramucirumab; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2

    Percentage of patients with objective response per RECIST 1.1

    Measured: Last randomized patient on study at least 16 weeks

  2. Phase 3

    Overall Survival

    Measured: From the date of randomization to the date of death (due to any cause), up to 36 months postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start15 Jan 2022
  3. Primary completion24 May 2024
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002127
Sponsor's protocol ID
AT148006
Status last verified
Nov 2026
First submitted
27 Jul 2021
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shitara K, Wainberg Z, Tabernero J, Van Cutsem E, Coutzac C, De La Fouchardiere C, Lee J, Rha SY, Kang YK, Fanning P, Forgie A, Mao C, Brickman D, Pons J, Tsiatis AC, Randolph S, Lee KW. Evorpacept plus trastuzumab, ramucirumab and paclitaxel in HER2-positive gastric cancer: a randomized phase 2 trial. Nat Med. 2026 Sep 24. doi: 10.1038/s41591-026-04700-3. Online ahead of print.

    PubMed 42786305

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Evorpacept (ALX148), Trastuzumab and Ramucirumab in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by ALX Oncology Inc. at 83 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in South Korea, Japan, Spain, France, Taiwan and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2 (time frame: Last randomized patient on study at least 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05002127, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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