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
This trial does not accept healthy volunteersQualifiers
Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol.
Male participants greater than equal to (>=)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
Sequential
Treatments tested in this trial
GSK5458514
DrugGSK5458514 will be administered.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with dose limiting toxicities (DLTs) during DLT observation period
Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity
Number of participants with AEs leading to dose modifications
Secondary outcomes
Area under concentration from 0 to t (AUC 0-t) of GSK5458514
Maximum concentration (Cmax) of GSK5458514
Time to reach maximum concentration (Tmax) of GSK5458514
Number of participants with Anti-drug antibodies (ADA) against GSK5458514
Sponsors and contacts
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