A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and dose optimization study of GSK5471713 in adult participants with metastatic castration resistant prostate cancer (mCRPC).

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523874-17-00

Enrollment

Registered

2026-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Prostate

Brief summary

Number of participants with dose limiting toxicities (DLTs) at each dose level, Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose modifications, Severity of adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose modifications

Detailed description

Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713, Maximum plasma concentration (Cmax) of GSK5471713, Time to maximum plasma concentration (tmax) of GSK5471713, Prostate-specific antigen decrease from baseline >=50% (PSA50) response rate, Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment

Interventions

None listed

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of participants with dose limiting toxicities (DLTs) at each dose level, Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose modifications, Severity of adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose modifications	—

Secondary

Measure	Time frame
Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713, Maximum plasma concentration (Cmax) of GSK5471713, Time to maximum plasma concentration (tmax) of GSK5471713, Prostate-specific antigen decrease from baseline >=50% (PSA50) response rate, Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment	—

Outcome results