A Phase 12 Study of GSK5458514 Targeting PSMA, Alone or With Other Cancer Treatments, for Adult Men With Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety and how the body processes a drug called GSK5458514 in men with metastatic castration-resistant prostate cancer. The study includes two parts an initial dose escalation phase and a dose expansion phase. It is an open-label, multicenter study led by GlaxoSmithKline, focusing on adult men with advanced prostate cancer that has progressed despite prior treatments. In the first part, participants receive increasing doses of GSK5458514 alone to determine the appropriate dose. The second part expands the dose group to further assess the drug alone or in combination with other anti-cancer agents. Treatment is given under medical supervision, and participants are monitored for side effects, dose-limiting toxicities, and how the drug behaves in the body over time. Participants are involved in regular visits for evaluations including safety checks, blood tests, imaging scans, and tumor tissue sampling for biomarker analysis. Researchers measure adverse events, drug concentrations, immune responses, and prostate-specific antigen changes. The study includes ongoing monitoring for up to about 29 to 32 months to assess safety and treatment responses. Participation lasts through both study phases and follow-up periods as scheduled.

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