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A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors
Sponsor: GlaxoSmithKline
Summary
The primary purpose of this study is to determine the maximum tolerated dose of GSK4524101 monotherapy (MTD) and GSK4524101 in combination with niraparib (MTDc). The study consists of two parts - Part 1 (Dose Escalation) and Part 2 (Dose Expansion).
Official title: A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP Inhibitor (PARPi) Niraparib in Adult Participants With Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2023-10-24
Completion Date
2026-06-30
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
GSK4524101
GSK452101 will be administered.
Niraparib
Niraparib will be administered.
Locations (13)
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
St Louis, Missouri, 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
Fairfax, Virginia, United States
GSK Investigational Site
Porto Alegre, Brazil
GSK Investigational Site
Vitória, Brazil
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Panama City, Panama
GSK Investigational Site
Punta Pacifica Panama City Panama, Panama