Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
MALE
NCT07332455

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

Led by GlaxoSmithKline · Updated on 2026-04-22

54

Participants Needed

6

Research Sites

215 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male adults with metastatic castration-resistant prostate cancer confirmed by biopsy or cytology
  • Prostate cancer progression while receiving androgen deprivation therapy
  • ECOG performance status of 0 or 1 indicating good functional ability
  • Disease progression on androgen deprivation therapy and at least one prior androgen receptor pathway inhibitor
  • Received one to two prior taxane-based chemotherapy regimens
Not Eligible

You will not qualify if you...

  • Diagnosis of small cell or neuroendocrine carcinoma of the prostate or any histology other than adenocarcinoma
  • Impaired heart function or clinically significant heart disease
  • Any serious medical condition such as uncontrolled infection or significant lab abnormalities
  • Previous treatment with androgen receptor degrader targeted therapies
  • Other protocol-specific exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

GSK Investigational Site

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

2

GSK Investigational Site

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

3

GSK Investigational Site

West Valley City, Utah, United States, 84119

Actively Recruiting

4

GSK Investigational Site

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

5

GSK Investigational Site

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

6

GSK Investigational Site

Tokyo, Japan, 135-8550

Actively Recruiting

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Research Team

U

US GSK Clinical Trials Call Center

CONTACT

E

EU GSK Clinical Trials Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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