NCT05007782

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part D allocation for 1 cohort will be randomized.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Denikitug	Administered Intravenously
DRUG	Zimberelimab	Administered Intravenously

Timeline

• Start date: 2021-08-18
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2021-08-16
• Last updated: 2025-12-29

Locations

26 sites across 5 countries: United States, Australia, Canada, Spain, Taiwan

Regulatory

• FDA-regulated drug study