NCT06167317

Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors. The primary objectives of this study are to: * To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors * To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GS-0201	Pill administered orally
DRUG	Sacituzumab Govitecan	Administered intravenously

Timeline

• Start date: 2024-01-09
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2023-12-12
• Last updated: 2025-03-12

Locations

7 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study