Neoplasms, Prostate
Conditions
Brief summary
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
Detailed description
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)
Interventions
None listed
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
France, Spain
Outcome results
None listed