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

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

First listed

Apr 14, 2026

Start date

May 19, 2026

Status verified

Jun 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

• Gilead Clinical Study Information Center
  1-833-445-3230 (GILEAD-0)
  [email protected]

Locations (5)

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