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NCT Number: NCT05329766

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Toronto, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.

Treatment and study plan

Domvanalimab

Drug

Administered as specified in the treatment arm

Quemliclustat

Drug

Administered as specified in the treatment arm

Zimberelimab

Drug

Administered as specified in the treatment arm

Fluorouracil

Drug

Administered as specified in the treatment arm

Leucovorin

Drug

Administered as specified in the treatment arm

Oxaliplatin

Drug

Administered as specified in the treatment arm

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

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Acronym: EDGE-Gastric

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2022
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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