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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
Study Purpose
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
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
Exclusion Criteria:
Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: Part 1 - GSK4524101 Monotherapy
Experimental: Part 1 - GSK4524101 plus Niraparib
Experimental: Part 1 - GSK4524101 Food Effect Cohort
Experimental: Part 2 - GSK4524101 plus Niraparib
Active Comparator: Part 2 - Niraparib
Interventions
Drug: - GSK4524101
GSK452101 will be administered.
Drug: - Niraparib
Niraparib will be administered.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
GSK Investigational Site
San Francisco, California, 94158
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Status
Recruiting
Address
GSK Investigational Site
Miami, Florida, 33136
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Status
Recruiting
Address
GSK Investigational Site
Saint Louis, Missouri, 63110
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Status
Recruiting
Address
GSK Investigational Site
Dallas, Texas, 75230
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Status
Recruiting
Address
GSK Investigational Site
Houston, Texas, 77030
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Status
Recruiting
Address
GSK Investigational Site
San Antonio, Texas, 78229
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Status
Recruiting
Address
GSK Investigational Site
Fairfax, Virginia, 22031
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
International Sites
Status
Recruiting
Address
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Status
Recruiting
Address
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Status
Recruiting
Address
GSK Investigational Site
Toronto, Ontario, M5G 2M9
Site Contact
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
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