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NCT Number: NCT07332455

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

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.

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Key information

Conditions

Neoplasms, Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GSK Investigational Site, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK5471713

Drug

GSK5471713 will be administered at different dose levels based on the dose escalation study design

Primary outcomes

  1. Number of participants with dose limiting toxicities (DLTs)

    Time frame: 28 days

  2. Number of participants with adverse events (AEs), and serious adverse events (SAEs)

    Time frame: Approximately 45 months

  3. Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity

    Time frame: Approximately 45 months

  4. Number of participants with AEs leading to dose modifications

    Time frame: Approximately 45 months

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of GSK5471713

    Time frame: Approximately 45 months

  2. Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713

    Time frame: Approximately 45 months

  3. Time to maximum plasma concentration (Tmax) of GSK5471713

    Time frame: Approximately 45 months

  4. Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate

    Time frame: Approximately 45 months

    PSA50 response is defined as a greater than or equal to (>=)50 percent (%) decline in PSA from Baseline, confirmed at least 3 weeks later.

  5. Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment

    Time frame: Approximately 45 months

    ORR is defined as the percentage of participants in the ORR Evaluable set who have the Best overall response (BOR) of confirmed Complete response (CR) or Partial response (PR) per PCWG3 guidelines as assessed by investigator.

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jan 12, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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