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NCT07527858 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Gilead Sciences.

Recruiting
Registry status
Phase 2
Development phase
170
Enrollment target

NCT07527858: Recruiting Phase 2 study, sponsored by Gilead Sciences.

NCT07527858 is a Phase 2 study that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 170 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07527858, a Phase 2 study, is actively recruiting participants, sponsored by Gilead Sciences.

RECRUITING
Registry status
Phase 2
Development phase
170 participants
Enrollment target

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).

Primary Outcome

ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.

Interventions

  • DRUG Bevacizumab
  • DRUG Nivolumab
  • DRUG Denikitug
  • DRUG Trifluridine-Tipiracil

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2026-05-19
Est. Completion 2028-12
Phase Phase 2
Gilead Sciences

504 total trials

What NCT07527858 shows while recruiting

NCT07527858 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% higher).

The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.

NCT07527858 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07527858 about?

NCT07527858 is a clinical study titled "Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer". 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 ...

What is the current status of trial NCT07527858?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2026-05-19. Estimated completion is 2028-12.

What interventions are being tested in trial NCT07527858?

The interventions under investigation include: Bevacizumab (DRUG), Nivolumab (DRUG), Denikitug (DRUG), Trifluridine-Tipiracil (DRUG).

Who is sponsoring clinical trial NCT07527858?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07527858's enrollment target sits among peer trials

170 399th of 2000 higher than 1,598 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07527858, the US trial registry maintained by the National Library of Medicine. NCT07527858 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.