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Study of Denikitug for Gastric, GEJ, and Esophageal Adenocarcinomas

This study is testing Denikitug (GS-1811) alone or in combination with other approved drugs like Nivolumab, Ramucirumab, and Paclitaxel. It's for adults with HER2-negative (a type of protein found on cancer cells) advanced stomach (gastric), gastroesophageal junction (GEJ), or esophageal (food pipe) adenocarcinomas that cannot be removed by surgery or have spread. The main goal is to see how many participants respond to the treatment. The study plans to enroll 120 people, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 120 participants. It is evaluating Denikitug as a single treatment or in combination with other medications.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Objective Response Rate (ORR) will be measured for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07546812

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Gilead Sciences
~120 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:DenikitugNivolumabRamucirumabPaclitaxel

At a glance

Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Up to 4 years

Conditions

HER2-negative
Gastroesophageal Junction
Esophageal Adenocarcinoma
Gastric Adenocarcinoma

Explore related trials

Esophageal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaClaudin-18 Isoform A2

NCT07546812

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Centre Leon Berard, department of medical oncology

    Lyon, Franceno site contact published

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, Australiano site contact published

    Recruiting

  • Hollywood Private Hospital

    Nedlands, Western Australia, Australiano site contact published

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, Spainno site contact published

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spainno site contact published

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Spainno site contact published

    Recruiting

  • Institut Paoli-Calmettes, department of medical oncology

    Marseille, Franceno site contact published

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).
Human epidermal growth factor receptor 2 (HER2)-negative status, as determined by local assessment using a validated immunohistochemistry assay, in situ hybridization or other amplification testing.
Has had disease progression during or after first line of systemic therapy for advanced or metastatic gastric, GEJ, or EACs, which must have included at least one of the following:
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Have adequate organ function.
Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.

Exclusion

Active or history of autoimmune disease requiring systemic treatment within 2 years, inflammatory bowel disease (IBD) (Crohn's/ulcerative colitis), celiac disease, or noninfectious enteritis/colitis. (Physiologic hormone replacement not considered systemic treatment).
History or current noninfectious pneumonitis/interstitial lung disease, including radiation-induced pneumonitis requiring steroids or active/recurrent pneumonitis of any etiology.
Documented microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) disease by local polymerase chain reaction (PCR) (microsatellite status) and/or informed consent form (ICH) (mismatch repair (MMR)) assay
(For Part 2 only) Has known history of peripheral neuropathy ≥ Grade 2 (per National Cancer Institute(NCI)-Common Tenninology Criteria for Adverse Events (CTCAE) Version 5.0).
(For Part 2 only) Known coagulopathy that increases the risk of bleeding, bleeding diatheses. Any other Grade 3 or higher hemorrhage/bleeding event within 28 days prior to enrollment.
Prior treatment with DEN or other C-C chemokine receptor 8 (CCR8)-targeted agents.
Prior Lonsurf (trifluridine-tipiracil) or paclitaxel (PAC)-based regimens in the first-line setting for advanced/metastatic gastroesophageal adenocarcinoma.
Any systemic therapy (including investigational) targeting vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) signaling pathways.
Anticancer biologic within 4 weeks, orchemotherapy, targeted small molecule, or radiation therapy within 2 weeks prior to enrollment with unresolved adverse events (AE)s (Grade \>2). (Observational study participants are eligible).
Prior allogenic tissue/solid organ or stem cell transplantation. (Exception: corneal transplant not requiring systemic immunosuppression is allowed).

What this trial measures

  • 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.