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

Last updated: February 17, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

1/2

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

GSK5471713

Clinical Study ID

NCT07332455
300164
2025-523874-17
  • Ages > 18
  • Male

Study 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

Inclusion

Inclusion Criteria:

  • Participants with mCRPC that have histologically or cytologically confirmedadenocarcinoma of the prostate.

  • Participants with mCRPC that has prostate cancer progression while on Androgendeprivation therapy (ADT).

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

  • Progression on ADT and >=1 prior Androgen receptor pathway inhibitors (ARPI) forHormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens.

Exclusion

Exclusion Criteria:

  • Pathological finding consistent with small cell, neuroendocrine carcinoma of theprostate, or any histology different from adenocarcinoma.

  • Impaired cardiac function or clinically significant cardiac disease.

  • Any significant medical condition, such as uncontrolled infection or clinicallysignificant laboratory abnormality.

  • Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Otherprotocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 54
Treatment Group(s): 1
Primary Treatment: GSK5471713
Phase: 1/2
Study Start date:
February 10, 2026
Estimated Completion Date:
March 26, 2030

Connect with a study center

  • GSK Investigational Site

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Site Not Available

  • GSK Investigational Site

    West Valley City 5784607, Utah 5549030 84119
    United States

    Site Not Available

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