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Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors
Sponsor: GlaxoSmithKline
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
107
Start Date
2020-06-25
Completion Date
2026-12-31
Last Updated
2025-10-27
Healthy Volunteers
No
Conditions
Interventions
GSK6097608
GSK6097608 will be administered as an IV infusion.
Dostarlimab
Dostarlimab will be administered as an IV infusion.
Cobolimab
Cobolimab will be administered as an IV infusion.
Belrestotug
Belrestotug will be administered as an IV infusion.
Locations (11)
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea