Clinical Trial

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

Recruiting Phase 2
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Summary
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).
Protocol Amendment History 2 changes
notable Trial sites expanded: 1 -> 4 locations 2026-07-11
critical Recruitment opened 2026-05-19
Trial Details
NCT Number NCT07546812
Lead Sponsor Gilead Sciences
Conditions HER2-negative, Gastroesophageal Junction, Esophageal Adenocarcinoma, Gastric Adenocarcinoma
Enrollment 120 participants
Start Date 2026-07
Primary Completion 2030-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-10