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NCT07546812 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Gilead Sciences.

Recruiting
Registry status
Phase 2
Development phase
120
Enrollment target

NCT07546812: Recruiting Phase 2 study, sponsored by Gilead Sciences.

NCT07546812 is a Phase 2 study that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07546812, a Phase 2 study, is actively recruiting participants, sponsored by Gilead Sciences.

RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target

Study 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).

Primary Outcome

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.

Interventions

  • DRUG Nivolumab
  • DRUG Paclitaxel
  • DRUG Ramucirumab
  • DRUG Denikitug

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2026-07
Est. Completion 2030-01
Phase Phase 2
Gilead Sciences

504 total trials

What NCT07546812 shows while recruiting

NCT07546812 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).

The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.

NCT07546812 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07546812 about?

NCT07546812 is a clinical study titled "Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas". 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, an...

What is the current status of trial NCT07546812?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2026-07. Estimated completion is 2030-01.

What interventions are being tested in trial NCT07546812?

The interventions under investigation include: Nivolumab (DRUG), Paclitaxel (DRUG), Ramucirumab (DRUG), Denikitug (DRUG).

Who is sponsoring clinical trial NCT07546812?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07546812's enrollment target sits among peer trials

120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07546812, the US trial registry maintained by the National Library of Medicine. NCT07546812 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.