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ACTIVE NOT RECRUITING
NCT05277051
PHASE1

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of remzistotug in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

Official title: A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2022-03-22

Completion Date

2027-08-31

Last Updated

2026-03-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

Remzistotug

Remzistotug will be administered.

DRUG

Dostarlimab

Dostarlimab will be administered.

DRUG

Belrestotug

Belrestotug will be administered.

DRUG

Nelistotug

Nelistotug will be administered.

DRUG

GSK5764227

GSK5764227 will be administered.

Locations (26)

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Jinan, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Wuhan, China

GSK Investigational Site

Dijon, France

GSK Investigational Site

Lille, France

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Manchester, United Kingdom

GSK Investigational Site

Sutton, United Kingdom