Trial · NCT07546812
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas
NCT07546812, Phase 2, Active not recruiting, Gilead Sciences
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas. Trials, record NCT07546812. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07546812
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas
- NCT number
- NCT07546812
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Gilead Sciences
- Conditions
- HER2-negative, Gastroesophageal Junction, Esophageal Adenocarcinoma, Gastric Adenocarcinoma
- Interventions
- Denikitug, Nivolumab, Ramucirumab, Paclitaxel
- First posted
- 2026-04-23
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 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. |
| Secondary | Duration of Response (DOR) | 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. |
| Secondary | Progression-Free Survival (PFS) | 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. |
| Secondary | Overall Survival (OS) | Up to 4 years | OS is defined as the length of time from first dose until the date of death from any cause. |
| Secondary | 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 | First dose date up to 120 days post last dose, up to 4 years. | |
| Secondary | Percentage of Participants Experiencing Clinical Laboratory Abnormalities According to the NCI CTCAE v5.0 | First dose date up to 120 days post last dose, up to 4 years. | |
| Secondary | Pharmacokinetic (PK) Parameter: Serum concentration of DEN | Up to 4 years | |
| Secondary | PK Parameter: Cmax for Denikitug | Up to 4 years | Cmax is defined as the maximum observed concentration. |
| Secondary | PK Parameter: AUCall for Denikitug | Up to 4 years | AUCall is defined as the cumulative areas under the curve for all time points. |
| Secondary | Percentage of Participants who Developed Treatment-Emergent Antidrug Antibody (ADA) Against Denikitug | Up to 4 years |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07546812
GET https://conductscience.org/api/trials/v1/NCT07546812/registered