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Gastrointestinal Tract MalignanciesPhase 2EDGE-GastricNCT05329766

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

A Phase 2 study testing Domvanalimab, Quemliclustat and Zimberelimab in people with Gastrointestinal Tract Malignancies, run by Arcus Biosciences, Inc. at 43 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Tract Malignancies
What is being tested?
Domvanalimab, Quemliclustat and Zimberelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
332 participants
Where
43 sitesin 6 countries
Study dates
10 Jun 2022to 7 Sep 2026
Phase
Phase 2
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

  • Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator
  • Eastern cooperative oncology group (ECOG) Performance Score of 0-1
  • At least one measurable target lesion per RECIST v1.1.
  • Adequate organ and marrow function
  • Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing

Who cannot join

  • Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
  • Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor
  • Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases 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.

Trial locations and contacts

43 sites in 6 countries.

43 sites in 6 countries

United States17 sites

  • Research Site

    Boston, Massachusetts, 02109

  • Research Site

    Columbus, Ohio, 43219

  • Research Site

    Derby, Connecticut, 06418

  • Research Site

    Durham, North Carolina, 27710

  • Research Site

    Fairfax, Virginia, 22031

  • Research Site

    Fort Myers, Florida, 33901

  • Research Site

    Jacksonville, Florida, 32224

  • Research Site

    Los Angeles, California, 90033

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    Nashville, Tennessee, 37232

  • Research Site

    New York, New York, 10021-0005

  • Research Site

    New York, New York, 10032

  • Research Site

    Oklahoma City, Oklahoma, 73104

  • Research Site

    Phoenix, Arizona, 85054

  • Research Site

    Portland, Oregon, 97213

  • Research Site

    Santa Monica, California, 90024

  • Research Site

    St. Petersburg, Florida, 33705

Other trials in United States

France12 sites

  • Research Site

    Bordeaux

  • Research Site

    Brest

  • Research Site

    Caen

  • Research Site

    Lille

  • Research Site

    Lyon

  • Research Site

    Marseille

  • Research Site

    Montpellier

  • Research Site

    Plérin

  • Research Site

    Poitiers

  • Research Site

    Rouen

  • Research Site

    Toulouse

  • Research Site

    Villejuif

Other trials in France

South Korea6 sites

  • Research Site

    Busan

  • Research Site

    Daegu

  • Research Site

    Hwasun

  • Research Site

    Seongnam-si

  • Research Site

    Seoul

  • Research Site

    Suwon

Other trials in South Korea

Chile4 sites

  • Research Site

    Las Condes

  • Research Site

    Recoleta

  • Research Site

    Santiago

  • Research Site

    Talca

Other trials in Chile

Serbia3 sites

  • Research Site

    Belgrade

  • Research Site

    Kamenitz

  • Research Site

    Kragujevac

Other trials in Serbia

Canada1 site

  • Research Site

    Toronto

Other trials in Canada

About this study

Official title: A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)

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).

Being tested
Domvanalimab, Quemliclustat, Zimberelimab, Fluorouracil, Leucovorin
Keywords
Domvanalimab, Quemliclustat, Zimberelimab, Esophageal adenocarcinoma, Gastric adenocarcinoma, Gastric cancer, Gastroesophageal junction cancer, Anti-PD-1 antibody, Anti-CD73, anti-TIGIT antibody
Medical subject headings
Adenocarcinoma Of Esophagus, Stomach Neoplasms

What participants receive

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

  • DomvanalimabDrug

    Administered as specified in the treatment arm

  • QuemliclustatDrug

    Administered as specified in the treatment arm

  • ZimberelimabDrug

    Administered as specified in the treatment arm

  • FluorouracilDrug

    Administered as specified in the treatment arm

  • LeucovorinDrug

    Administered as specified in the treatment arm

  • OxaliplatinDrug

    Administered as specified in the treatment arm

Study groups in NCT05329766
Study groupRoleWhat they receive
A1: First Line - Treatment Naïve ParticipantsExperimentalDomvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W)
Receives: Drug: Domvanalimab; Drug: Zimberelimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin
A2: First Line - Treatment Naïve ParticipantsExperimentalZimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W
Receives: Drug: Zimberelimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin
A3 First Line - Treatment Naïve ParticipantsExperimentalNon-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
Receives: Drug: Domvanalimab; Drug: Zimberelimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin
A4 First Line - Treatment Naïve ParticipantsExperimentalZimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W
Receives: Drug: Zimberelimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin
B1: Second Line or greater Checkpoint Inhibitor Naïve ParticipantsExperimentalDomvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion
Receives: Drug: Domvanalimab; Drug: Zimberelimab
B2: Second Line or greater Checkpoint Inhibitor Naïve ParticipantsExperimentalQuemliclustat Q2W and zimberelimab Q4W administered by IV infusion
Receives: Drug: Quemliclustat; Drug: Zimberelimab
Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced ParticipantsExperimentalDomvanalimab and zimberelimab Q3W administered by IV infusion
Receives: Drug: Domvanalimab; Drug: Zimberelimab

What is being measured

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

  1. Number of Participants with Adverse Events (AEs)

    Measured: Up to 18 months

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

    Measured: Up to 18 months

Secondary outcomes (10)

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

    Measured: Up to 18 months

  2. Overall survival (OS)

    Measured: 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

    Measured: Up to 18 months

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

    Measured: Up to 18 months

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

    Measured: Up to 18 months

  6. Plasma concentration of domvanalimab

    Measured: Up to 18 months

  7. Plasma concentration of zimberelimab

    Measured: Up to 18 months

  8. Plasma concentration of quemliclustat

    Measured: Up to 18 months

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

    Measured: Up to 18 months

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

    Measured: Up to 18 months

Timeline

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

  1. First posted15 Apr 2022
  2. Study start10 Jun 2022
  3. Primary completion7 Sep 2026
  4. Study completion7 Sep 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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329766
Sponsor's protocol ID
ARC-21
Other IDs
2021-006291-16, 2024-511917-40-00
Acronym
EDGE-Gastric
Status last verified
Apr 2026
First submitted
8 Apr 2022
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Domvanalimab, Quemliclustat and Zimberelimab in people with Gastrointestinal Tract Malignancies, run by Arcus Biosciences, Inc. at 43 sites in 6 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 5 inclusion and 6 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, France, South Korea, Chile, Serbia and 1 more country. 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 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.

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?

Number of Participants with Adverse Events (AEs) (time frame: Up to 18 months). 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 NCT05329766, 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 26 Oct 2026.

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