NCT07546812 Denikitug Adenocarcinoma of Esophagus Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07546812 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07546812 is a hot trial to watch
Adenocarcinoma of Esophagus is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07546812 is notable because it evaluates Denikitug in a Phase 2 design sponsored by Gilead Sciences, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07546812 |
| Official title | Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Denikitug |
| Sponsor | Gilead Sciences, Inc. |
| Geography | United States, Australia |
| Enrollment | [object Object] |
| Primary endpoint | Objective Response Rate (ORR) |
| Endpoint time frame | Up to 4 years |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
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).
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across United States, Australia shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- 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.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
Build a living trial monitor: connect to PatSnap MCP Servers and track recruitment, endpoint revisions, projected readouts and new result records without manually reconciling separate databases.
Asset and sponsor context
Drug & Asset MCP profile: Denikitug is indexed as Monoclonal antibody, with target CCR8, mechanism CCR8 inhibitor, ADCC, Regulatory T-lymphocytes inhibitors, and global highest development status Phase 2.
Company & Deal Intelligence MCP profile: Gilead Sciences, Inc. is resolved to a normalized organization record in SAN MATEO COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07546812 provides a focused lens on Adenocarcinoma of Esophagus development. Its value will be determined by whether Denikitug can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
Ready to reproduce this analysis? Explore PatSnap MCP Servers and combine Clinical Trials, Drug & Asset, and Company & Deal Intelligence as reusable building blocks for trial monitoring and SEO-ready clinical reports.
