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NCT05007782 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor, sponsored by Gilead Sciences.

Recruiting
Registry status
Phase 1
Development phase
416
Enrollment target
20
Study locations

NCT05007782 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 416 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (118% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT05007782, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by Gilead Sciences.

RECRUITING
Registry status
Phase 1
Development phase
416 participants
Enrollment target
20
Study locations

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

504 total trials

What the Registry Record Tells You About NCT05007782

The ClinicalTrials.gov registry entry for NCT05007782 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (118% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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.

NCT05007782 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Texas, California.

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.

What interventions are being tested in trial NCT05007782?

The interventions under investigation include: Zimberelimab (DRUG), Denikitug (DRUG).

Who is sponsoring clinical trial NCT05007782?

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

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.