ClinicalTrials.gg
CompletedNCT05002127Updated Nov 5, 2026

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

A Phase 2/3 interventional study of Evorpacept (ALX148) and Trastuzumab in Gastric Cancer, Gastroesophageal Junction Adenocarcinoma and Gastric Adenocarcinoma, sponsored by ALX Oncology Inc.. Completed at 83 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by ALX Oncology Inc. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2024, 2 years 5 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in May 2025.
Updated Nov 5, 2026Now CompletedGo to Updates ↓

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Phase
Phase 2/3
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 521 studies in Stomach Neoplasms with a site in Korea, Republic of — 78 open to participants now, 116 under way, 20 of them phase 3. Stomach Neoplasms · Korea, Republic of.

Enrollment
181st of 448
127 · median 95
Started
2022
with 29 others
Phase 2/3
7 of 521
1 open now
Registered
393rd of 521
by date

Among the 521 studies in Stomach Neoplasms with a site in Korea, Republic of, this one is the 181st largest by enrollment of the 448 interventional ones that give a count, is one of 30 that started in 2022, is one of 7 in phase 2/3, and was the 393rd registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

78 of the 521 studies in Stomach Neoplasms with a site in Korea, Republic of are open now. Recruiting first, the newest first:

73 more — sign in →

All 78 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

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.

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.

03

Conditions studied

  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Gastric Adenocarcinoma

Browse trials for

Keywords

  • ALX148
  • CD47
  • SIRPα
  • Gastric
  • Gastroesophageal
  • GEJ
  • HER2 positive
  • Ramucirumab
  • Evorpacept
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • -overexpressing advanced or gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy ( or 3rd-line)
  • Adequate Bone Marrow Function.
  • Adequate Renal \& Liver Function.
  • Adequate Performance Status

Exclusion criteria

Exclusion Criteria:

  • Patients with known symptomatic central nervous system (CNS) or requiring .
  • Prior treatment with any anti-7 or anti-SIRPα agent.
  • Prior treatment with ramucirumab.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
127 participants (actual)

Study arms

  • 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) · Drug: Trastuzumab · Drug: Ramucirumab · Drug: Paclitaxel

  • 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 · Drug: Ramucirumab · Drug: Paclitaxel

  • 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) · Drug: Trastuzumab · Drug: Ramucirumab · Drug: Paclitaxel

  • 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 · Drug: Paclitaxel

Interventions

06

What researchers measure

Primary outcomes

  1. Phase 2

    Percentage of patients with objective response per RECIST 1.1

    Time frame: Last randomized patient on study at least 16 weeks

  2. Phase 3

    Overall Survival

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

07

Study locations

83 sites
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in May 2024, 28 months.

Of 26 phase 2/3 interventional studies under Stomach Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 52. This study's 28 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2021
First posted
Aug 12, 2021
StartActual
Jan 15, 2022
Primary completionActual
May 24, 2024
CompletionActual
Jun 30, 2026
Results delay requested
May 23, 2025
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Nov 5, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 42786305 ↗
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Active, not recruiting→Completed
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 42786305 ↗
    + 3 other changes: verification date, date precision and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05002127
Lead sponsor
ALX Oncology Inc.
Responsible party
Sponsor
First posted
Aug 12, 2021
Start date
Jan 15, 2022
Primary completion
May 24, 2024
Completion
Jun 30, 2026
Last update
Nov 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: ALX148

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