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

Phase
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Arcus Biosciences, Inc.
Start date
Number of sites

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).
Acronym
EDGE-Gastric
Short title
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
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)

Control arm
Registry reports results
Listing at source
Recruitment status
Active, not recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Arcus Biosciences, Inc.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Number of Participants with Adverse Events (AEs)

    Timeframe: Up to 18 months

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

    Timeframe: Up to 18 months

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

    Timeframe: Up to 18 months

  2. Overall survival (OS)

    Timeframe: 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

    Timeframe: Up to 18 months

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

    Timeframe: Up to 18 months

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

    Timeframe: Up to 18 months

  6. Plasma concentration of domvanalimab

    Timeframe: Up to 18 months

  7. Plasma concentration of zimberelimab

    Timeframe: Up to 18 months

  8. Plasma concentration of quemliclustat

    Timeframe: Up to 18 months

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

    Timeframe: Up to 18 months

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

    Timeframe: Up to 18 months

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

Sources for eligibility

  • Research SitePhoenix, United States
  • Research SiteLos Angeles, United States
  • Research SiteSanta Monica, United States
  • Research SiteDerby, United States
  • Research SiteFort Myers, United States
  • Research SiteJacksonville, United States
  • Research SiteSt. Petersburg, United States
  • Research SiteBoston, United States
  • Research SiteNew York, United States
  • Research SiteNew York, United States
  • Research SiteDurham, United States
  • Research SiteColumbus, United States
  • Research SiteOklahoma City, United States
  • Research SitePortland, United States
  • Research SiteNashville, United States
  • Research SiteNashville, United States
  • Research SiteFairfax, United States
  • Research SiteToronto, Canada
  • Research SiteLas Condes, Chile
  • Research SiteRecoleta, Chile
  • Research SiteSantiago, Chile
  • Research SiteTalca, Chile
  • Research SiteBordeaux, France
  • Research SiteBrest, France
  • Research SiteCaen, France

And 18 more, listed on the interactive page.

Sources for sites

  • 2024-511917-40-00
  • 2021-006291-16
Sources for references

Related records

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Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (3)