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Brief Title: A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors
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
Study ID: NCT06077877
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, San Francisco, California, United States
GSK Investigational Site, Miami, Florida, United States
GSK Investigational Site, Saint 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, Edmonton, Alberta, Canada
GSK Investigational Site, Ottawa, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR