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

Sponsor
Gilead Sciences
Study ID
NCT07546812
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction
  • HER2-negative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Denikitug — DRUG
    Administered Intravenously
  • Nivolumab — DRUG
    Administered Intravenously
  • Ramucirumab — DRUG
    Administered Intravenously
  • Paclitaxel — DRUG
    Administered Intravenously

Study Details

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).

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Arm A: DEN (Dose A) and NIVO
    Participants will receive DEN Dose A as an IV infusion in combination with NIVO as an IV infusion.
  • Experimental: Part 1: Arm B: DEN (Dose B) and NIVO
    Participants will receive DEN Dose B as an IV infusion in combination with NIVO as an IV infusion.
  • Experimental: Part 1: Arm C: DEN (Dose B)
    Participants will receive DEN Dose B as an IV infusion.
  • Experimental: Part 2: Arm D: Safety Run-in (SRI) Cohort
    Participants will receive DEN in combination with ramucirumab (RAM) and paclitaxel (PAC). If dose for DEN is deemed safe during the SRI Cohort, the study will move forward into the Expansion Period.
  • Experimental: Part 2: Arm D: Expansion Cohort
    If DEN dose is deemed safe in Arm D: SRI Cohort, participants will receive DEN at recommended dose as an IV infusion in combination with RAM and PAC.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]

Central Contacts

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