First-Time-in-Human Study of GSK5471713 in Adults With mCRPC

GlaxoSmithKline (GSK)

Status and phase

Begins enrollment this month

Phase 2

Phase 1

Conditions

Neoplasms, Prostate

Treatments

Drug: GSK5471713

Study type

Interventional

Funder types

Industry

Identifiers

NCT07332455

2025-523874-17 (Other Identifier)

300164

Details and patient eligibility

About

This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a monotherapy in mCRPC.

Enrollment

54 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate.
Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Progression on ADT and >=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens.

Exclusion criteria

Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma.
Impaired cardiac function or clinically significant cardiac disease.
Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality.
Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/exclusion criteria apply.