Last updated: 01/09/2026 06:40:21

First-Time-in-Human study of GSK5471713 in adults with mCRPC

GSK study ID
300164
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
2025-523874-17
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with dose limiting toxicities (DLTs)

Timeframe: 28 days

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

Timeframe: Approximately 45 months

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

Timeframe: Approximately 45 months

Number of participants with AEs leading to dose modifications

Timeframe: Approximately 45 months

Secondary outcomes:

Maximum plasma concentration (Cmax) of GSK5471713

Timeframe: Approximately 45 months

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

Timeframe: Approximately 45 months

Time to maximum plasma concentration (Tmax) of GSK5471713

Timeframe: Approximately 45 months

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

Timeframe: Approximately 45 months

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

Timeframe: Approximately 45 months

Interventions:
  • Drug: GSK5471713
    • Enrollment:
    54
    Primary completion date:
    2028-12-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Prostate
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    February 2026 to April 2030
    Type
    Interventional
    Phase
    1/2

    Participation criteria

    Sex
    Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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).
    • 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.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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