🏛️ Verified NIH Record • Updated 2025-12-26

Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (NCT05007782)

A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (GS-1811), an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Gilead Sciences

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of California San Diego — La Jolla, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

  • University of California San Diego — La Jolla, California
  • Stanford Cancer Center — Palo Alto, California
  • Smilow Cancer Center — New Haven, Connecticut
  • Beth Israel Deaconess Medical Center — Boston, Massachusetts
  • Tennessee Oncology, PLLC — Nashville, Tennessee
  • University of Texas Southwestern Medical Center — Dallas, Texas
  • Sarah Cannon Research Institute at Mary Crowley — Dallas, Texas
  • MD Anderson Cancer Center — Houston, Texas
  • NEXT Oncology — San Antonio, Texas
  • University of Wisconsin Clinical Sciences Center — Madison, Wisconsin
  • Chris O'Brien Lifehouse — Camperdown, New South Wales
  • Monash Medical Centre — Clayton, Victoria
  • Peter MacCallum Cancer Centre — Melbourne, Victoria
  • 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,
  • Chi Mei Hospital, Liouying — Tainan,
  • National Taiwan University Cancer Center (NTUCC) — Taipei,
  • National Taiwan University Hospital — Taipei,
  • Taipei Tzu Chi General Hospital — Taipei,
  • Taipei Veterans General Hospital — Taipei,

📞 Contact the Study Coordinator

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗