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Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas

StatusRecruiting
PhasePhase 2
Started2026-08-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
Trial sites expanded: 12 → 15 locations
2026-08-20
Study Status, Contacts/Locations v3
Trial sites expanded: 4 → 12 locations
Start dateestimated 2026-07→confirmed 2026-08-07
2026-07-09
Study Status, Contacts/Locations v2
Trial sites expanded: 1 → 4 locations
Start date2026-05→2026-07
2026-05-14
Study Status, Study Description, Eligibility, Contacts/Locations, References v1
Recruitment opened
Start date2026-04→2026-05
Study sites0→1
Eligibility criteria+178 characters
[...] phageal junction (GEJ), or esophageal adenocarcinoma (EAC). Human epidermal growth factor receptor 2 (HER2)-negative status, as determined by local assessment using a [...] ived prior PD-1/PD-L1-based therapy). Zolbetuximab or other Claudin-18 (CLDN18).2-targeted therapy, if indicated based on biomarker status. [...] immune disease requiring systemic treatment within 2 years, inflammatory bowel disease (IBD) (Crohn's/ulcerative colitis), celiac disease, or noninfecti [...] ) Has known history of peripheral neuropathy ≥ Grade 2 (per National Cancer Institute(NCI)-Common Tenninology Criteria for Adverse Events (CTC [...] [...]
2026-04-17
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
Gastric Cancer
1,194 trials monitored
See 60 trials at risk
Esophageal Cancer
1,010 trials monitored
See 51 trials at risk
The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and/or metastatic, gastroesophageal junction (GEJ), and esophageal adenocarcinomas. The primary objective of this study is to assess the effect of DEN as a monotherapy or in combination with nivolumab (NIVO) or ramucirumab (RAM) and paclitaxel (PAC) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version1.1).
Trial Details
NCT Number NCT07546812
Lead Sponsor Gilead Sciences
Conditions HER2-negative, Gastroesophageal Junction, Esophageal Adenocarcinoma, Gastric Adenocarcinoma
Enrollment 120 participants
Start Date 2026-08-07
Primary Completion 2030-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-21