Study on GSK5458514 Alone or with Other Cancer Drugs for Prostate Cancer

Sponsor: GlaxoSmithKline

Sponsor score: 60

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

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

FACILITYZIPCITYSTATE
GSK Investigational Site80218DenverColorado
GSK Investigational Site37203NashvilleTennessee

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