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

Sponsor
Gilead Sciences
Study ID
NCT07527858
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Advanced Microsatellite Stable Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Denikitug — DRUG
    Administered Intravenously
  • Nivolumab — DRUG
    Administered Intravenously
  • Bevacizumab — DRUG
    Administered Intravenously
  • Trifluridine-Tipiracil — DRUG
    Administered orally

Study Details

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).

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DEN monotherapy (Arm A)
    Participants will receive DEN via intravenous (IV) infusion.
  • Experimental: DEN in combination with NIVO (Arm B)
    Participants will receive DEN as an IV infusion in combination with NIVO as an IV infusion.
  • Experimental: DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C)
    Participants will receive DEN as an IV infusion in combination with BVZ as an IV infusion and FTD-TPI administered orally. Includes a Safety Run-in cohort (non-randomized cohort) prior to randomization.
  • Active Comparator: Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D)
    Participants will receive BVZ as an IV infusion and FTD-TPI administered orally as SOC.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 60 months ]

Central Contacts