ClinicalTrials.gg
CompletedNCT05329766EDGE-GastricUpdated Oct 26, 2026

A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies

A Phase 2 interventional study of Domvanalimab and Quemliclustat in Gastrointestinal Tract Malignancies, sponsored by Arcus Biosciences, Inc.. Completed at 43 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Arcus Biosciences, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 26, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
332
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 246 studies in Adenocarcinoma Of Esophagus with a site in United States — 53 open to participants now, 73 under way, 7 of them phase 3. Adenocarcinoma Of Esophagus · United States.

Enrollment
25th of 203
332 · median 49
Started
2022
with 6 others
Phase 2
125 of 246
17 open now
Registered
191st of 246
by date

Among the 246 studies in Adenocarcinoma Of Esophagus with a site in United States, this one is the 25th largest by enrollment of the 203 interventional ones that give a count, is one of 7 that started in 2022, is one of 125 in phase 2, and was the 191st registered.

Adenocarcinoma Of Esophagus

354 studies on the registry are indexed under Adenocarcinoma Of Esophagus; 81 are open to participants now.

Browse Adenocarcinoma Of Esophagus studies →

Open to participants now

53 of the 246 studies in Adenocarcinoma Of Esophagus with a site in United States are open now. Recruiting first, the newest first:

48 more — sign in →

All 53 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 70 Adenocarcinoma Of Esophagus studies recruiting now, 60 (86%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.

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

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 246 studies in Adenocarcinoma Of Esophagus with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).

03

Conditions studied

  • Gastrointestinal Tract Malignancies

Keywords

  • Domvanalimab
  • Quemliclustat
  • Zimberelimab
  • Esophageal adenocarcinoma
  • Gastric adenocarcinoma
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Anti-PD-1 antibody
  • Anti-CD73
  • anti-TIGIT antibody
04

Who can participate

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

Eligibility criteria

Key Inclusion Criteria:

  • Participants with confirmed diagnosis of locally advanced unresectable or gastric, GEJ, or esophageal adenocarcinoma with ≥3 months as assessed by the Investigator
  • (ECOG) Performance Score of 0-1
  • At least one measurable target lesion per v1.1.
  • Adequate organ and marrow function
  • Able to provide an that is representative of the cancer under investigation and suitable for central testing

Key Exclusion Criteria:

  • Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of products hazardous
  • Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 () positive tumor
  • Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with are excluded from enrollment.
  • Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody.
  • History of trauma or major surgery within 28 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Terms in these criteria, in plain language(10)

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

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

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
332 participants (actual)

Study arms

  • Experimental
    A1: First Line - Treatment Naïve Participants

    Domvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W)

    Drug: Domvanalimab · Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin

  • Experimental
    A2: First Line - Treatment Naïve Participants

    Zimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W

    Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin

  • Experimental
    A3 First Line - Treatment Naïve Participants

    Non-randomized A3 safety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W. After completion of A3 safety run-in cohort, participants are randomized to the A3 arm. Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W

    Drug: Domvanalimab · Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin

  • Experimental
    A4 First Line - Treatment Naïve Participants

    Zimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W

    Drug: Zimberelimab · Drug: Fluorouracil · Drug: Leucovorin · Drug: Oxaliplatin

  • Experimental
    B1: Second Line or greater Checkpoint Inhibitor Naïve Participants

    Domvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion

    Drug: Domvanalimab · Drug: Zimberelimab

  • Experimental
    B2: Second Line or greater Checkpoint Inhibitor Naïve Participants

    Quemliclustat Q2W and zimberelimab Q4W administered by IV infusion

    Drug: Quemliclustat · Drug: Zimberelimab

  • Experimental
    Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants

    Domvanalimab and zimberelimab Q3W administered by IV infusion

    Drug: Domvanalimab · Drug: Zimberelimab

Interventions

  • Administered as specified in the treatment arm

  • Administered as specified in the treatment arm

  • Administered as specified in the treatment arm

  • Administered as specified in the treatment arm

  • Administered as specified in the treatment arm

  • Administered as specified in the treatment arm

06

What researchers measure

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 18 months

  2. Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Up to 18 months

Secondary outcomes

  1. Objective Response Rate (ORR) as measured by PD-L1 Expression Level

    Time frame: Up to 18 months

  2. Overall survival (OS)

    Time frame: From date of first dose until the date of death due to any cause (approximately 18 months)

  3. Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 18 months

  4. Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks

    Time frame: Up to 18 months

  5. Duration of response (DOR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 18 months

  6. Plasma concentration of domvanalimab

    Time frame: Up to 18 months

  7. Plasma concentration of zimberelimab

    Time frame: Up to 18 months

  8. Plasma concentration of quemliclustat

    Time frame: Up to 18 months

  9. Percentage of participants with anti-drug antibodies to domvanalimab

    Time frame: Up to 18 months

  10. Percentage of participants with anti-drug antibodies to zimberelimab

    Time frame: Up to 18 months

07

Study locations

43 sites
  • Research Site
    Phoenix, Arizona 85054, United States
  • Research Site
    Los Angeles, California 90033, United States
  • Research Site
    Santa Monica, California 90024, United States
  • Research Site
    Derby, Connecticut 06418, United States
  • Research Site
    Fort Myers, Florida 33901, United States
  • Research Site
    Jacksonville, Florida 32224, United States
  • Research Site
    St. Petersburg, Florida 33705, United States
  • Research Site
    Boston, Massachusetts 02109, United States
  • Research Site
    New York, New York 10021-0005, United States
  • Research Site
    New York, New York 10032, United States
  • Research Site
    Durham, North Carolina 27710, United States
  • Research Site
    Columbus, Ohio 43219, United States
  • Research Site
    Oklahoma City, Oklahoma 73104, United States
  • Research Site
    Portland, Oregon 97213, United States
  • Research Site
    Nashville, Tennessee 37203, United States
  • Research Site
    Nashville, Tennessee 37232, United States
  • Research Site
    Fairfax, Virginia 22031, United States
  • Research Site
    Toronto, Canada
  • Research Site
    Las Condes, Chile
  • Research Site
    Recoleta, Chile
  • Research Site
    Santiago, Chile
  • Research Site
    Talca, Chile
  • Research Site
    Bordeaux, France
  • Research Site
    Brest, France
  • Research Site
    Caen, France
  • Research Site
    Lille, France
  • Research Site
    Lyon, France
  • Research Site
    Marseille, France
  • Research Site
    Montpellier, France
  • Research Site
    Plérin, France
  • Research Site
    Poitiers, France
  • Research Site
    Rouen, France
  • Research Site
    Toulouse, France
  • Research Site
    Villejuif, France
  • Research Site
    Belgrade, Serbia
  • Research Site
    Kamenitz, Serbia
  • Research Site
    Kragujevac, Serbia
  • Research Site
    Busan, South Korea
  • Research Site
    Daegu, South Korea
  • Research Site
    Hwasun, South Korea
  • Research Site
    Seongnam-si, South Korea
  • Research Site
    Seoul, South Korea
  • Research Site
    Suwon, South Korea
08

References and documents

Publications

  • Janjigian YY, Oh DY, Pelster M, Wainberg ZA, Prusty S, Nelson S, DuPage A, Thompson A, Koralek DO, Sison EAR, Rha SY. Domvanalimab and zimberelimab in advanced gastric, gastroesophageal junction or esophageal cancer: a phase 2 trial. Nat Med. 2025 Dec;31(12):4274-4280. doi: 10.1038/s41591-025-04022-w. Epub 2025 Oct 18. PubMed 41109921 ↗

Individual participant data

Plan to share: Yes — Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Data sharing details ↗ · trials.arcusbio.com

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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 Jun 2022 to primary completion in Sep 2026, 50 months.

Of 60 phase 2 interventional studies under Adenocarcinoma Of Esophagus, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 80. This study's 50 months is close to that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: primary completion Jan 2027 → Sep 2026 and completion Jun 2027 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Apr 8, 2022
First posted
Apr 15, 2022
StartActual
Jun 10, 2022
Primary completionActual
Sep 7, 2026was Jan 2027
CompletionActual
Sep 7, 2026was Jun 2027
Last update
Oct 26, 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 Oct 26, 2026
Sites
1 site added
Show site
  • Research Site · Portland, United States
Sep 29, 2026
Primary completion
Jan 2027→Sep 7, 2026 (actual)
Oct 26, 2026
Study completion
Jun 2027→Sep 7, 2026 (actual)
Oct 26, 2026
Show all 2 updates
  1. Oct 26, 2026
    Active, not recruiting→Completed
    Primary completion Jan 2027→Sep 7, 2026 (now actual)
    Study completion Jun 2027→Sep 7, 2026 (now actual)
  2. Sep 29, 2026
    1 site added
    Show site
    • Research Site · Portland, United States

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
NCT05329766
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Apr 15, 2022
Start date
Jun 10, 2022
Primary completion
Sep 7, 2026
Completion
Sep 7, 2026
Last update
Oct 26, 2026

Study contacts

Medical Director
study director · Arcus Biosciences, Inc.

Oversight

Data monitoring committee
No
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 Apr 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Domvanalimab · Quemliclustat

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