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New treatment option for Advanced Microsatellite Stable Colorectal Cancer
Official title Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
ClinicalTrials.gov ID: NCT07527858
What this study is testing
What is Denikitug?
Denikitug is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced microsatellite stable colorectal cancer.
Also referred to as GS-1811, DEN.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key Medical History/Physical Characteristics
- Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS...
- Documented MSS or proficient mismatch repair (pMMR) disease by local assessment using a validated polymerase chain reaction (PCR) (microsatellite...
- Has received up to 2 prior lines of systemic therapy for advanced or metastatic CRC, which must have included at least fluoropyrimidine-...
- Documented progressive disease (PD) by computed tomography (CT) or magnetic resonance imaging (MRI) during or after the most recent therapy per...
You likely can't join if
- 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...
- Trifluridine-tipiracil, regorafenib, or fruquitinib.
See the full eligibility criteria
- Key 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...
- 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...
- 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
- 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...
- 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...
- Allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed. Note: Other...
The study team makes the final eligibility decision.
Where it's taking place
- North Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Sioux Falls, South Dakota, United States
- Charlottesville, Virginia, United States
- Camperdown, CA, Australia
- Herston, Queensland, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Haven, Connecticut, United States; Boston, Massachusetts, United States; Sioux Falls, South Dakota, United States; Charlottesville, Virginia, United States; Camperdown, CA, Australia; Herston, Queensland, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.