drugset / Trial / NCT05007782

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

NCT05007782

Phase 1 Recruiting 416 enrolled Gilead Sciences
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2021-08-18
Primary completion
2028-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Denikitug Monoclonal antibody Intravenous
Subject Zimberelimab Monoclonal antibody Intravenous

Indications