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Spots Global Cancer Trial Database for A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

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Trial Identification

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

Conditions

Neoplasms

Interventions

GSK4524101
Niraparib

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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