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

Recruiting now · Phase 1/Phase 2

Conditions studied: Neoplasms, Prostate

In brief

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.

Key facts

Study ID

NCT07332455

Run by

GlaxoSmithKline

People needed

54

Starts

2026-02-10

Expected to finish

2030-03-26

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — La Jolla, California, United States (enrolling)
• GSK Investigational Site — Grand Rapids, Michigan, United States (enrolling)
• GSK Investigational Site — Philadelphia, Pennsylvania, United States (enrolling)
• GSK Investigational Site — West Valley City, Utah, United States (enrolling)
• GSK Investigational Site — Melbourne, Victoria, Australia (enrolling)
• GSK Investigational Site — Toronto, Ontario, Canada (enrolling)
• GSK Investigational Site — Montreal, Quebec, Canada (enrolling)
• GSK Investigational Site — Tokyo, Japan (enrolling)
• GSK Investigational Site — Tokyo, Japan (enrolling)
• GSK Investigational Site — Seoul, Seoul Teugbyeolsi, South Korea (enrolling)
• GSK Investigational Site — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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