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ACTIVE NOT RECRUITING
NCT06077877
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

DRUG

GSK4524101

GSK452101 will be administered.

DRUG

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