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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Administered Intravenously
Administered Intravenously
Administered Intravenously
Administered Intravenously
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGNew York Oncology Hematology
Albany, New York, United States
RECRUITINGWeill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States
RECRUITINGChris O'Brien Lifehouse
Camperdown, New South Wales, Australia
RECRUITINGRoyal North Shore Hospital
St Leonards, New South Wales, Australia
RECRUITINGRoyal Brisbane and Women's Hospital
Herston, Queensland, Australia
RECRUITINGFlinders Medical Centre
Bedford Park, South Australia, Australia
RECRUITINGHollywood Private Hospital
Nedlands, Western Australia, Australia
RECRUITINGCentre Leon Berard, department of medical oncology
Lyon, France
RECRUITING...and 5 more locations
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.
Time frame: Up to 4 years
Duration of Response (DOR)
DOR is defined as the time of first response CR or PR as assessed by investigator, per RECIST Version 1.1 until the date of first documented progressive disease (PD) or death, whichever comes first.
Time frame: Up to 4 years
Progression-Free Survival (PFS)
PFS is defined as the time from date of first dose until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1.
Time frame: Up to 4 years
Overall Survival (OS)
OS is defined as the length of time from first dose until the date of death from any cause.
Time frame: Up to 4 years
Percentage of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: First dose date up to 120 days post last dose, up to 4 years.
Percentage of Participants Experiencing Clinical Laboratory Abnormalities According to the NCI CTCAE v5.0
Time frame: First dose date up to 120 days post last dose, up to 4 years.
Pharmacokinetic (PK) Parameter: Serum concentration of DEN
Time frame: Up to 4 years
PK Parameter: Cmax for Denikitug
Cmax is defined as the maximum observed concentration.
Time frame: Up to 4 years
PK Parameter: AUCall for Denikitug
AUCall is defined as the cumulative areas under the curve for all time points.
Time frame: Up to 4 years
Percentage of Participants who Developed Treatment-Emergent Antidrug Antibody (ADA) Against Denikitug
Time frame: Up to 4 years
Gilead Clinical Study Information Center
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