A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorGlaxoSmithKline

About this trial

The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).

Eligibility criteria

Qualifiers

Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Male participants ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.

Histologically or cytologically confirmed adenocarcinoma of the prostate

Metastatic disease diagnosed either by radiologic imaging (Positron emission tomography [PET]- Computed tomography [CT]) and/or regular CT and/or Magnetic resonance imaging (MRI) and/or bone scan

Disqualifiers

Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any histology different from adenocarcinoma.

History of central nervous system (CNS) metastases or leptomeningeal disease.

History of an invasive malignancy for which the participant was definitively treated, and in which the participant has been disease free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted disease under study

Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and/or in situ breast cancer may be enrolled

Trial design

Treatments tested in this trial

  • GSK5458514

Treatment groups

85 Participants
are divided into 2 treatment groups

Sponsors and collaborators