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RECRUITING Phase 1

Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors

NCT05007782 · View on ClinicalTrials.gov ↗

Study Summary

This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors. This study will be conducted in 6 parts (Parts A, B, and E: monotherapy, Parts C and D: combination therapy, and Part F for both monotherapy and combination therapy) in participants with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or in participants with select solid tumors.

Conditions Studied

Interventions

  • DRUG Zimberelimab
  • DRUG Denikitug

Study Locations (20)

Other

  • University Health Network, Princess Margaret Cancer Centre — Toronto
  • Hospital Universitari Vall d´Hebrón — Barcelona
  • MD Anderson Cancer Center — Madrid
  • Hospital Universitario 12 de Octubre — Madrid
  • Hospital Universitario Quironsalud Madrid — Madrid
  • Clinica Universidad de Navarra — Pamplona
  • Changhua Christian Hospital — Changhua

Texas

  • University of Texas Southwestern Medical Center — Dallas
  • Sarah Cannon Research Institute at Mary Crowley — Dallas
  • MD Anderson Cancer Center — Houston
  • NEXT Oncology — San Antonio

California

  • University of California San Diego — La Jolla
  • Stanford Cancer Center — Palo Alto

Victoria

  • Monash Medical Centre — Clayton
  • Peter MacCallum Cancer Centre — Melbourne

Connecticut

  • Smilow Cancer Center — New Haven

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

Tennessee

  • Tennessee Oncology, PLLC — Nashville

Wisconsin

  • University of Wisconsin Clinical Sciences Center — Madison

Trial Details

FieldValue
Enrollment Target 416 participants
Start Date 2021-08-18
Est. Completion 2028-12
Phase Phase 1

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05007782

The ClinicalTrials.gov registry entry for NCT05007782 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which Zimberelimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05007782 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05007782 about?

NCT05007782 is a clinical study titled "Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors". This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumor...

What is the current status of trial NCT05007782?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 416 participants. The study started on 2021-08-18. Estimated completion is 2028-12.

What conditions does trial NCT05007782 study?

This clinical trial studies the following conditions: Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05007782?

The interventions under investigation include: Zimberelimab (DRUG), Denikitug (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05007782?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05007782 being conducted?

This trial has 20 study locations across California, Connecticut, Massachusetts, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial