Not Yet RecruitingPhase 2

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

120 participantsStarted 2026-04

Plain-language 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 denikitug (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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Platinum- and fluoropyrimidine-based chemotherapy.
✓. Therapy with an anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody (patients with PD-L1-positive tumors must have received prior PD-1/PD-L1-based therapy).
✓. Zolbetuximab or other CLDN18.2-targeted therapy, if indicated based on biomarker status.

What they're measuring

Objective Response Rate (ORR)

Timeframe: Up to 4 years

Trial details

NCT IDNCT07546812

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-01

Contact for this trial

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

View on ClinicalTrials.gov More HER2-negative trials