Study Details

OVERVIEW

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)

PROTOCOL 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).

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Advanced Microsatellite Stable Colorectal Cancer

Gender

N/A

Date

May 2026 - December 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Denikitug, Nivolumab, Bevacizumab, Trifluridine-Tipiracil

Eligibility Information

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.

Exclusion Criteria

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.

Locations

Locations (8)

Yale-New Haven Hospital - Yale Cancer Center

North Haven, Connecticut, United States, 06473 2195

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

University of Virginia,

Charlottesville, Virginia, United States, 22908

Chris O'Brien Lifehouse

Camperdown, CA, Australia, 2050

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia, 4029

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

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