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NCT07332455PHASE1, PHASE2Recruiting

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

GlaxoSmithKline

Start Date

2/10/2026

Completion Date

3/26/2030

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

GSK5471713

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Conditions

Neoplasms, Prostate

Locations

GSK Investigational Site

La Jolla, California 92093

United States

GSK Investigational Site

Grand Rapids, Michigan 49546

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19107

United States

GSK Investigational Site

West Valley City, Utah 84119

United States

GSK Investigational Site

Melbourne, Victoria 3000

Australia

GSK Investigational Site

Toronto, Ontario M5G 2M9

Canada

GSK Investigational Site

Montreal, Quebec H4A 3J1

Canada

GSK Investigational Site

Tokyo, 104-0045

Japan

GSK Investigational Site

Tokyo, 135-8550

Japan

GSK Investigational Site

Seoul, Seoul Teugbyeolsi 06351

South Korea

GSK Investigational Site

Seoul, 120-752

South Korea