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New hope for Hard-to-Treat colorectal cancer? denikitug trial launches

NCT ID NCT07527858

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Updated 4 times

Summary

This phase 2 trial tests a new drug called denikitug, alone or combined with other treatments, in 170 people with advanced microsatellite stable (MSS) colorectal cancer. MSS colorectal cancer is a common type that often does not respond to standard immunotherapy. The study aims to see if denikitug can shrink tumors and improve outcomes.

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, trifluridine-tipiracil, or bevacizumab
What this could lead to
If successful, this could offer a new treatment option for people with advanced MSS colorectal cancer, a type that typically does not respond to immunotherapy.
What could go wrong
This is an early phase 2 trial with a small number of participants. The drug may not shrink tumors or improve survival, and side effects are possible.

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 170 people

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

Started

May 2026

Expected to finish

Dec 2028

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: Medical History/Physical Characteristics * Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer). * Documented MSS or proficient mismatch repair (pMMR) disease by local assessment using a validated polymerase chain reaction (PCR) (microsatellite status) and/or immunohistochemistry (IHC) mismatch repair (MMR) assay is required. * Has received up to 2 prior lines of systemic therapy for advanced or metastatic CRC, which must have included at least fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies if indicated; and if applicable: anti-vascular endothelial growth factor (VEGF) therapy, anti epidermal growth factor receptor (EGFR) therapy, encorafenib or adagrasib/sotorasib. * Documented progressive disease (PD) by computed tomography (CT) or magnetic resonance imaging (MRI) during or after the most recent therapy per RECIST Version 1.1 criteria by investigator assessment. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. Laboratory Assessments * Have adequate organ function. Key Exclusion Criteria with: Medical Conditions/History: * Significant cardiovascular disease. * History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years. * History of (noninfectious) pneumonitis/interstitial lung disease or current pneumonitis/ interstitial lung disease. * History of gastrointestinal (GI) perforation, permanent ileostomy, abdominal abscess or fistula within 6 months, active or uncontrolled GI bleeding within 4 weeks, or any condition associated with significant risk of bleeding or perforation (eg, untreated varices, tumor erosion, recent GI surgery). Prior/Concurrent Therapy or Clinical Study Experience Prior treatment with: * Trifluridine-tipiracil, regorafenib, or fruquitinib. * Any immuno-oncology therapy. * Anticancer biologic agent within 4 weeks prior to randomization or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to randomization and have not recovered (ie, Grade 2 or less) from AEs from prior anticancer therapy at the time of randomization. Individuals in observational studies are eligible. * Allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

colorectal cancer

As listed by the trial registrant

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

Advanced microsatellite stable colorectal cancer

How to take part

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

  1. The places running it

    13 sites in 4 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

  • Asan Medical Center

    NOT_YET_RECRUITING

    Seoul, 138-736, South Korea

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, CA, 2050, Australia

  • Dana-Farber Cancer Institute

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Hospital General Universitario Gregorio Maranon

    NOT_YET_RECRUITING

    Madrid, 28050, Spain

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Royal Brisbane and Women's Hospital

    RECRUITING

    Herston, Queensland, 4029, Australia

  • Samsung Medical Center

    NOT_YET_RECRUITING

    Busan, 48775, South Korea

  • Seoul National University Hospital

    NOT_YET_RECRUITING

    Seoul, 03080, South Korea

  • University of Virginia,

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Washington University School of Medicine

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale-New Haven Hospital - Yale Cancer Center

    RECRUITING

    North Haven, Connecticut, 06473 2195, United States

  • Yonsei University Severance Hospital ( aka Yonsei Cancer Center)

    NOT_YET_RECRUITING

    Seoul, 03722, South Korea