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New drug combo shows promise for Tough-to-Treat stomach cancers

NCT ID NCT07546812

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 3 times

Summary

This Phase 2 trial is testing a new drug called denikitug, alone or combined with other cancer drugs, in 120 people with advanced HER2-negative stomach, gastroesophageal junction, or esophageal cancer that has worsened after initial treatment. The main goal is to see if the drug can shrink tumors. Researchers will also track how long any response lasts and how long participants live without the cancer growing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Denikitug (also called GS-1811), given alone or with nivolumab, ramucirumab, or paclitaxel
What this could lead to
If successful, this could provide a new treatment option for people with advanced stomach or esophageal cancer that has stopped responding to initial therapy.
What could go wrong
This is an early Phase 2 trial with only 120 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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: 1. Platinum- and fluoropyrimidine-based chemotherapy. 2. Therapy with an anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody (patients with PD-L1-positive tumors must have received prior PD-1/PD-L1-based therapy). 3. Zolbetuximab or other Claudin-18 (CLDN18).2-targeted therapy, if indicated based on biomarker status. * 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. Key Exclusion Criteria: * 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/Concurrent Therapy or Clinical Study Experience * 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). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus esophageal adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal adenocarcinoma Gastric adenocarcinoma Gastroesophageal junction HER2-negative

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Leon Berard, department of medical oncology

    RECRUITING

    Lyon, 69008, France

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Dana Farber Cancer Institute (DFCI)

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Hollywood Private Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Institut Paoli-Calmettes, department of medical oncology

    RECRUITING

    Marseille, 13009, France

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • New York Oncology Hematology

    RECRUITING

    Albany, New York, 12206, United States

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Herston, Queensland, 4029, Australia

  • Royal North Shore Hospital

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03830, South Korea

  • Weill Cornell Medicine - New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.