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Clinical Trials in the USA / NCT07527858
Recruiting Phase 2

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

NCT07527858 · tracked via the Priya Life Science USA tracker
Sponsor
Gilead Sciences
Phase
Phase 2
Started
2026-05-19
Last updated
2026-07-28

Condition(s) studied

Advanced Microsatellite Stable Colorectal Cancer

Investigational drug(s) / intervention(s)

DenikitugNivolumabBevacizumabTrifluridine-Tipiracil

Denikitug: Administered Intravenously

Nivolumab: Administered Intravenously

Bevacizumab: Administered Intravenously

Trifluridine-Tipiracil: Administered orally

Study 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).

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Yale-New Haven Hospital - Yale Cancer Center North Haven Connecticut Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Active Not Recruiting
Washington University School of Medicine St Louis Missouri Not Yet Recruiting
Avera Cancer Institute Sioux Falls South Dakota Recruiting
University of Virginia, Charlottesville Virginia Recruiting
Chris O'Brien Lifehouse Camperdown CA Recruiting
Royal Brisbane and Women's Hospital Herston Queensland Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Samsung Medical Center Busan South Korea Not Yet Recruiting
Seoul National University Hospital Seoul South Korea Not Yet Recruiting
Yonsei University Severance Hospital ( aka Yonsei Cancer Center) Seoul South Korea Not Yet Recruiting
Asan Medical Center Seoul South Korea Not Yet Recruiting
Hospital General Universitario Gregorio Maranon Madrid Spain Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07527858 on ClinicalTrials.gov ↗ ← All trials in the USA