Denikitug for Advanced Colorectal Cancer

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

Recruiting Phase 2 Interventional Study
Advanced Microsatellite Stable Colorectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
Gilead Sciences · Industry
Who this trial is looking for

This trial is looking for adults with advanced colorectal cancer that cannot be cured by surgery. Participants will take the study drug Denikitug alone or in combination with other treatments to see how well it works.

Are You a Good Fit for This Trial?
Must not be taking Trifluridine-tipiracilRegorafenibFruquitinibImmuno-oncology therapy
Rules you out Autoimmune diseaseCardiovascular disease

You may be able to join if

  • I have been diagnosed with advanced microsatellite stable colorectal cancer.
  • I have had up to 2 prior treatments for my cancer.
  • I have documented progressive disease after my last treatment.
  • I have an ECOG performance status score of 0-1.
  • I have adequate organ function.

You may not be able to join if

  • I have significant cardiovascular disease.
  • I have a history of autoimmune disease that required treatment in the past 2 years.
  • I have had noninfectious pneumonitis or current lung disease.
  • I have had gastrointestinal bleeding or other serious GI conditions recently.
  • I have taken certain anticancer treatments or therapies recently.
  • I have had an organ transplant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 mism…
Contacts

Gilead Clinical Study Information Center

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

GileadClinicalTrials@gilead.com

CONTACT