Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2021-08-18 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT05007782 shows while recruiting
NCT05007782 is an interventional study that assigns participants to a tested intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (118% higher).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05007782's enrollment target sits among peer trials
416 20th of 189 higher than 170 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor 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
-
PM14 Administered Intravenously to Patients with Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
RECRUITING · Phase 1
-
Study of AVZO-021 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03527537 · 416 participants · Phase 4
Gestational Diabetes and Pharmacotherapy (GAP)
- NCT05520099 · 416 participants
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform
- NCT06075745 · 416 participants · Phase 2
Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates
- NCT06111040 · 416 participants · NA
Nurturing Needs Study: Parenting Food Motivated Children
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI