Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas
Start Date
8/7/2026
Completion Date
1/1/2030
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Denikitug
Nivolumab
Ramucirumab
Paclitaxel
Conditions
Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts 02215
United States
New York Oncology Hematology
Albany, New York 12206
United States
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York 10021
United States
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Royal North Shore Hospital
St Leonards, New South Wales 2065
Australia
Royal Brisbane and Women's Hospital
Herston, Queensland 4029
Australia
Flinders Medical Centre
Bedford Park, South Australia 5042
Australia
Hollywood Private Hospital
Nedlands, Western Australia 6009
Australia
Centre Leon Berard, department of medical oncology
Lyon, 69008
France
Institut Paoli-Calmettes, department of medical oncology
Marseille, 13009
France
Seoul National University Hospital
Seoul, 03830
South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain