A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of GSK5458514 PSMA targeting T cell engager alone or in combination with other anti-cancer agents in adult participants with metastatic castration-resistant prostate cancer (mCRPC)

Condition studied

Neoplasms, Prostate

Eligibility

Primary endpoint

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

Endpoint detail

GSK5458514 PK parameters following IV dose administration, as data permit - Area under concentration from 0 to t (AUC 0‑t) of GSK5458514 - Maximum concentration (Cmax) of GSK5458514, Number of participants with Anti-drug antibodies (ADA) against GSK5458514, Titers of Anti-drug antibodies (ADA) against GSK5458514, Prostate-specific antigen decrease from baseline >=50% (PSA50) Response Rate, Objective Response Rate (ORR)