RecruitingPhase 1NCT05277051

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

Sponsor

GlaxoSmithKline

Enrollment

158 participants

Start Date

Mar 22, 2022

Study Type

INTERVENTIONAL

Conditions

Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing GSK4381562, a brand-new experimental drug, for people with advanced or metastatic solid tumors including head and neck cancer, lung cancer, breast cancer, and others, where standard treatments have been exhausted. **You may be eligible if...** - You have a confirmed advanced or metastatic solid tumor (HNSCC, NSCLC, breast, or other solid tumors) - Curative treatment options are no longer available - You have measurable or evaluable disease - You meet reproductive safety requirements (contraception or confirmed non-childbearing status) - You are willing to provide tissue samples **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have significant uncontrolled medical conditions - You have had prior treatment with agents in the same drug class (if applicable) - You have active autoimmune disease requiring systemic therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelrestotug

Belrestotug will be administered.

DRUGNelistotug

Nelistotug will be administered.

DRUGGSK5764227

GSK5764227 will be administered.

DRUGRemzistotug

Remzistotug will be administered.

DRUGDostarlimab

Dostarlimab will be administered.

Locations(26)

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Dijon, France

GSK Investigational Site

Lille, France

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Sutton, United Kingdom

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Wuhan, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Jinan, China

GSK Investigational Site

Manchester, United Kingdom

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT05277051

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