Study on Denikitug (GS-1811) Alone or With Nivolumab or Chemotherapy for Advanced Colorectal Cancer
Sponsor: Gilead Sciences
ClinicalTrials ID:NCT07527858
This clinical trial is exploring the effects of a new drug, Denikitug, used alone or in combination with other treatments, to see if it can help treat advanced colorectal cancer that is stable in its genetic makeup.
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Program Overview
The purpose of this study is to learn more about a new drug called Denikitug (GS-1811) and how it works in treating advanced colorectal cancer that is stable in its genetic makeup. Researchers want to see if Denikitug, either by itself or combined with other drugs like Nivolumab or chemotherapy, can help shrink tumors in patients with this type of cancer. The study will measure how well the treatment works by looking at how much the tumors shrink, using standard criteria for evaluating cancer treatment responses.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced colorectal cancer that cannot be removed by surgery and is stable in its genetic makeup.
- Have received up to two previous treatments for advanced colorectal cancer, including specific chemotherapy drugs and, if applicable, other targeted therapies.
- Show evidence of cancer progression on recent scans after the last treatment.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function based on lab tests.
Exclusion Criteria
- Have significant heart disease.
- Have a history of autoimmune diseases that required treatment in the last two years.
- Have a history of lung diseases like pneumonitis or interstitial lung disease.
- Have had recent serious gastrointestinal issues, such as perforation, bleeding, or surgery.
- Have previously been treated with certain cancer drugs like Trifluridine-tipiracil or immunotherapy.
- Have had a recent organ transplant, except for a corneal transplant without the need for ongoing immune suppression.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale-New Haven Hospital - Yale Cancer Center | 06473 2195 | North Haven | Connecticut |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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