NCT04446351

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	GSK6097608	GSK6097608 will be administered as an IV infusion.
DRUG	Dostarlimab	Dostarlimab will be administered as an IV infusion.
DRUG	Cobolimab	Cobolimab will be administered as an IV infusion.
DRUG	Belrestotug	Belrestotug will be administered as an IV infusion.

Timeline

• Start date: 2020-06-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-06-24
• Last updated: 2025-10-27

Locations

11 sites across 4 countries: United States, Canada, Japan, South Korea

Regulatory

• FDA-regulated drug study