NCT05329766CompletedPhase 2
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 332 (actual)
- First submitted
- 8 Apr 2022
- Start date
- 10 Jun 2022
- Primary completion date
- 7 Sept 2026
- Lead sponsor
- Arcus Biosciences, Inc.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05329766
- EU CT number
- 2024-511917-40-00
- EudraCT number
- 2021-006291-16
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 332
- From 10 Jun 2022 to the primary completion date, 7 Sept 2026
- 41 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.