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Advanced Microsatellite Stable Colorectal CancerPhase 2NCT07527858

Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer

A Phase 2 study testing Denikitug, Nivolumab and Bevacizumab in people with Advanced Microsatellite Stable Colorectal Cancer, run by Gilead Sciences at 15 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 participants with advanced microsatellite stable (MSS) colorectal cancer (CRC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Denikitug, Nivolumab and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
15 sitesin 4 countries
Study dates
19 May 2026to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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 higher is considered not recovered) 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.

Trial locations and contacts

15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Gilead Clinical Study Information Center contact

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

15 sites in 4 countries

United States6 sites, 5 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Active, not recruiting

  • University of Virginia,

    Charlottesville, Virginia, 22908

    Recruiting

  • Yale-New Haven Hospital - Yale Cancer Center

    North Haven, Connecticut, 06473 2195

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Not yet recruiting

Other trials in United States

Australia4 sites, 4 recruiting

  • Chris O'Brien Lifehouse

    Camperdown, CA, 2050

    Recruiting

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

  • Royal North Shore Hospital

    Saint Leonards, Queensland, 2065

    Recruiting

Other trials in Australia

South Korea4 sites, 4 recruiting

  • Samsung Medical Center

    Busan, 48775

    Not yet recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Not yet recruiting

  • Yonsei University Severance Hospital ( aka Yonsei Cancer Center)

    Seoul, 03722

    Not yet recruiting

  • Asan Medical Center

    Seoul, 138-736

    Not yet recruiting

Other trials in South Korea

Spain1 site, 1 recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28050

    Not yet recruiting

Other trials in Spain

About this study

Official title: A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)

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 participants with advanced microsatellite stable (MSS) colorectal cancer (CRC).

The primary objective of this study is to assess the effect of DEN as monotherapy and in combination with nivolumab (NIVO) or trifluridine-tipiracil (FTD-TPI) and bevacizumab (BVZ) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1).

Being tested
Denikitug, Nivolumab, Bevacizumab, Trifluridine-Tipiracil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DenikitugDrug

    Also called GS-1811, DEN

    Administered Intravenously

  • NivolumabDrug

    Also called NIVO

    Administered Intravenously

  • BevacizumabDrug

    Also called BVZ

    Administered Intravenously

  • Trifluridine-TipiracilDrug

    Also called FTD-TPI

    Administered orally

Study groups in NCT07527858
Study groupRoleWhat they receive
DEN monotherapy (Arm A)ExperimentalParticipants will receive DEN via intravenous (IV) infusion.
Receives: Drug: Denikitug
DEN in combination with NIVO (Arm B)ExperimentalParticipants will receive DEN as an IV infusion in combination with NIVO as an IV infusion.
Receives: Drug: Denikitug; Drug: Nivolumab
DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C)ExperimentalParticipants will receive DEN as an IV infusion in combination with BVZ as an IV infusion and FTD-TPI administered orally. Includes a Safety Run-in cohort (non-randomized cohort) prior to randomization.
Receives: Drug: Denikitug; Drug: Bevacizumab; Drug: Trifluridine-Tipiracil
Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D)Active comparatorParticipants will receive BVZ as an IV infusion and FTD-TPI administered orally as SOC.
Receives: Drug: Bevacizumab; Drug: Trifluridine-Tipiracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    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.

    Measured: Up to 60 months

Secondary outcomes (9)

  1. Duration of response (DOR)

    DOR is defined as the time from 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.

    Measured: Up to 60 months

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from date of randomization until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1.

    Measured: Up to 60 months

  3. Overall Survival (OS)

    OS is defined as the length of time from randomization until the date of death from any cause.

    Measured: Up to 60 months

  4. Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Measured: First dose date up to 120 days post last dose, up to 60 months

  5. Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0

    Measured: First dose date up to 120 days post last dose, up to 60 months

  6. Pharmacokinetic (PK) Parameter: Serum concentration of Denikitug

    Measured: Up to 36 months

  7. PK Parameter: Cmax for Denikitug

    Cmax is defined as the maximum observed concentration.

    Measured: Up to 36 months

  8. PK Parameter: AUCall for Denikitug

    AUCall is defined as the cumulative areas under the curve for all time points.

    Measured: Up to 36 months

  9. Percentage of Participants who Developed Antidrug Antibody (ADA) Against Denikitug

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start19 May 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527858
Sponsor's protocol ID
GS-US-741-7756
Other IDs
2025-523984-39, 2025
Status last verified
Oct 2026
First submitted
7 Apr 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Denikitug, Nivolumab and Bevacizumab in people with Advanced Microsatellite Stable Colorectal Cancer, run by Gilead Sciences at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Australia, South Korea, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07527858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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