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Clinical Trial Finder

Search Results

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

  • - Part 1 (Dose Escalation) and Part 2 (Dose Expansion).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - More than or equal to (≥)18 years of age.
  • - Eastern cooperative oncology group (ECOG) class 0-2.
  • - Life expectancy of a minimum of 3 month.
  • - Participant has histologically diagnosed advanced or metastatic solid tumor and has exhausted all standard of care treatment options.

Exclusion Criteria:

  • - Participant has not recovered (i.e., to Grade less than or equal to [≤1] or to baseline) from prior chemotherapy-induced AEs.
  • - Participant is currently participating in a treatment study or has participated in a study of any investigational agent within 4 weeks of the first dose of treatment.
  • - Participant has symptomatic uncontrolled brain or leptomeningeal metastases.
  • - Participant has a known additional malignancy that progressed or required active treatment within the last 2 years.
  • - Participant has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
  • - Participant has uncontrolled hypertension with sustained systolic blood pressure (BP) >140 millimetres of mercury (mmHg) or diastolic BP >90 mmHg.

Trial Details

Trial ID:

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.

NCT06077877
Phase

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.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GlaxoSmithKline
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

GSK Clinical Trials
Principal Investigator Affiliation GlaxoSmithKline
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neoplasms
Arms & Interventions

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.

GSK Investigational Site, San Francisco, California

Status

Recruiting

Address

GSK Investigational Site

San Francisco, California, 94158

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

GSK Investigational Site, Miami, Florida

Status

Recruiting

Address

GSK Investigational Site

Miami, Florida, 33136

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

GSK Investigational Site, Saint Louis, Missouri

Status

Recruiting

Address

GSK Investigational Site

Saint Louis, Missouri, 63110

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

GSK Investigational Site, Dallas, Texas

Status

Recruiting

Address

GSK Investigational Site

Dallas, Texas, 75230

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

GSK Investigational Site, Houston, Texas

Status

Recruiting

Address

GSK Investigational Site

Houston, Texas, 77030

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

GSK Investigational Site, San Antonio, Texas

Status

Recruiting

Address

GSK Investigational Site

San Antonio, Texas, 78229

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

GSK Investigational Site, Fairfax, Virginia

Status

Recruiting

Address

GSK Investigational Site

Fairfax, Virginia, 22031

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

International Sites

GSK Investigational Site, Edmonton, Alberta, Canada

Status

Recruiting

Address

GSK Investigational Site

Edmonton, Alberta, T6G 1Z2

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

GSK Investigational Site, Ottawa, Ontario, Canada

Status

Recruiting

Address

GSK Investigational Site

Ottawa, Ontario, K1H 8L6

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

GSK Investigational Site, Toronto, Ontario, Canada

Status

Recruiting

Address

GSK Investigational Site

Toronto, Ontario, M5G 2M9

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

Resources

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Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

The THANC Foundation is a 501(c)(3) charitable organization.

Federal Tax ID 80-0062118.

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We are committed to supporting research and education in the early detection and treatment of thyroid and head and neck cancer; to advancing new therapeutic approaches; and to alleviating the suffering and functional impairment of patients who undergo treatment.

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