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πŸ›οΈ Verified NIH Protocol β€’ Sourced via U.S. National Library of Medicine (Last Synced: 2025-12-29)

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

🟒 Recruiting Phase 1 πŸ’Š Investigational Drug / Biologic Sponsor: Gilead Sciences

🩺 Protocol 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.

Primary Research Facility: University of California San Diego (La Jolla, California)

πŸ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

πŸ“ Primary Site Map

Site: University of California San Diego β€” La Jolla, California

πŸ“ All Participating Trial Locations (26 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. University of California San Diego β€” La Jolla, California
2. Stanford Cancer Center β€” Palo Alto, California
3. Smilow Cancer Center β€” New Haven, Connecticut
4. Beth Israel Deaconess Medical Center β€” Boston, Massachusetts
5. Tennessee Oncology, PLLC β€” Nashville, Tennessee
6. University of Texas Southwestern Medical Center β€” Dallas, Texas
7. Sarah Cannon Research Institute at Mary Crowley β€” Dallas, Texas
8. MD Anderson Cancer Center β€” Houston, Texas
9. NEXT Oncology β€” San Antonio, Texas
10. University of Wisconsin Clinical Sciences Center β€” Madison, Wisconsin
11. Chris O'Brien Lifehouse β€” Camperdown, New South Wales
12. Monash Medical Centre β€” Clayton, Victoria
13. Peter MacCallum Cancer Centre β€” Melbourne, Victoria
14. University Health Network, Princess Margaret Cancer Centre β€” United States
15. Hospital Universitari Vall dΒ΄HebrΓ³n β€” United States
16. MD Anderson Cancer Center β€” United States
17. Hospital Universitario 12 de Octubre β€” United States
18. Hospital Universitario Quironsalud Madrid β€” United States
19. Clinica Universidad de Navarra β€” United States
20. Changhua Christian Hospital β€” United States
21. Chi Mei Hospital, Liouying β€” United States
22. National Taiwan University Cancer Center (NTUCC) β€” United States
23. National Taiwan University Hospital β€” United States
24. Taipei Tzu Chi General Hospital β€” United States
25. Taipei Veterans General Hospital β€” United States

πŸ“„ Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

πŸ’° Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act Β§ 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

πŸ’‘ Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

πŸ›οΈ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05007782 β€’ Last Synced: 2025-12-29
View on ClinicalTrials.gov β†—
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