Denikitug
DrugAdministered Intravenously
Other names: GS-1811
NCT Number: NCT07546812
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Prior/Concurrent Therapy or Clinical Study Experience
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered Intravenously
Other names: GS-1811
Administered Intravenously
Administered Intravenously
Administered Intravenously
Time frame: Up to 4 years
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
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
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
OS is defined as the length of time from first dose until the date of death from any cause.
Time frame: First dose date up to 120 days post last dose, up to 4 years.
Time frame: First dose date up to 120 days post last dose, up to 4 years.
Time frame: Up to 4 years
Time frame: Up to 4 years
Cmax is defined as the maximum observed concentration.
Time frame: Up to 4 years
AUCall is defined as the cumulative areas under the curve for all time points.
Time frame: Up to 4 years
Contact information is provided by the study sponsor or research team.
Gilead Sciences
Industry
A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and/or Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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