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Active Not RecruitingNCT05277051

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

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

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

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.

Conditions

Interventions

TypeNameDescription
DRUGRemzistotugRemzistotug will be administered.
DRUGDostarlimabDostarlimab will be administered.
DRUGBelrestotugBelrestotug will be administered.
DRUGNelistotugNelistotug will be administered.
DRUGGSK5764227GSK5764227 will be administered.

Timeline

Start date
2022-03-22
Primary completion
2027-08-31
Completion
2027-08-31
First posted
2022-03-14
Last updated
2026-03-23

Locations

26 sites across 9 countries: United States, Australia, Canada, China, France, Japan, South Korea, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT05277051. Inclusion in this directory is not an endorsement.