Study on GSK5458514 Alone or with Other Cancer Drugs for Prostate Cancer
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT06990880
This clinical trial is testing the safety and how well the body handles a new drug, GSK5458514, when given alone or with other cancer treatments to men with prostate cancer. The study is divided into two parts: the first part will find the best dose, and the second part will test this dose in more patients.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate the safety and how well the body processes a new drug, GSK5458514, in men with prostate cancer. The study will be conducted in two phases: Part 1 will determine the best dose of the drug, and Part 2 will test this dose in a larger group of patients to see how well it works.
Eligibility Criteria
Inclusion Criteria
- Must provide signed informed consent and be able to follow study requirements.
- Male participants aged 18 or older.
- Agree not to donate sperm and either remain abstinent or use contraception during the study and for 195 days after the last dose.
- Have metastatic castration-resistant prostate cancer (mCRPC) confirmed by medical tests.
- Have previously tried and not responded to certain prostate cancer treatments.
- Have at least one measurable tumor or specific signs of cancer progression.
- Have low testosterone levels and be on continuous hormone therapy.
- Be in good general health with a performance status of 0 or 1.
- Provide a tumor sample for research purposes.
- Have adequate organ function as shown by medical tests.
Exclusion Criteria
- Have a type of prostate cancer other than adenocarcinoma.
- Have cancer that has spread to the brain or spinal fluid.
- Have had another invasive cancer in the last 5 years, except for certain treated skin or bladder cancers.
- Have ongoing side effects from previous treatments that have not improved.
- Have a history of autoimmune disease requiring treatment in the last 2 years.
- Have lung disease or a history of lung inflammation.
- Have received certain cancer treatments recently.
- Have had a bone marrow or organ transplant.
- Have allergies to study drugs or components.
- Have severe neurological or psychiatric disorders.
- Have had major surgery recently.
- Have serious infections or liver problems.
- Have hepatitis B or C infections.
- Cannot follow study procedures or requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 80218 | Denver | Colorado |
| GSK Investigational Site | 37203 | Nashville | Tennessee |
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