Gastrointestinal Tract Malignancies
Conditions
Keywords
Domvanalimab, Quemliclustat, Zimberelimab, Esophageal adenocarcinoma, Gastric adenocarcinoma, Gastric cancer, Gastroesophageal junction cancer, Anti-PD-1 antibody, Anti-CD73, anti-TIGIT antibody
Brief 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).
Interventions
DRUGDomvanalimab
Administered as specified in the treatment arm
DRUGQuemliclustat
Administered as specified in the treatment arm
DRUGZimberelimab
Administered as specified in the treatment arm
DRUGFluorouracil
Administered as specified in the treatment arm
DRUGLeucovorin
Administered as specified in the treatment arm
DRUGOxaliplatin
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 18 months |
| Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) as measured by PD-L1 Expression Level | Up to 18 months |
| Overall survival (OS) | From date of first dose until the date of death due to any cause (approximately 18 months) |
| Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1 | Up to 18 months |
| Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks | Up to 18 months |
| Duration of response (DOR) as determined by the Investigator according to RECIST v1.1 | Up to 18 months |
| Plasma concentration of domvanalimab | Up to 18 months |
| Plasma concentration of zimberelimab | Up to 18 months |
| Plasma concentration of quemliclustat | Up to 18 months |
| Percentage of participants with anti-drug antibodies to domvanalimab | Up to 18 months |
| Percentage of participants with anti-drug antibodies to zimberelimab | Up to 18 months |
Countries
Canada, Chile, France, Serbia, South Korea, United States
Contacts
STUDY_DIRECTORMedical Director
Arcus Biosciences, Inc.
Outcome results
None listed