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ACTIVE NOT RECRUITING
NCT04446351
PHASE1

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

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.

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