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Recruiting NCT07332455

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

Phase I / Phase II Interventional Neoplasms, Prostate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GSK5471713.
Who it may be relevant to
Registry conditions: Neoplasms, Prostate. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, Japan, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

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

Primary outcome measures

  • Number of participants with dose limiting toxicities (DLTs) [Time frame: 28 days]
  • Number of participants with adverse events (AEs), and serious adverse events (SAEs) [Time frame: Approximately 45 months]
  • Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity [Time frame: Approximately 45 months]
  • Number of participants with AEs leading to dose modifications [Time frame: Approximately 45 months]
Secondary outcome measures (5)
  • Maximum plasma concentration (Cmax) of GSK5471713 [Time frame: Approximately 45 months]
  • Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713 [Time frame: Approximately 45 months]
  • Time to maximum plasma concentration (Tmax) of GSK5471713 [Time frame: Approximately 45 months]
  • Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate [Time frame: Approximately 45 months]
  • Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment [Time frame: Approximately 45 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • GSK Investigational Site — La Jolla
  • GSK Investigational Site — Grand Rapids
  • GSK Investigational Site — Philadelphia
  • GSK Investigational Site — West Valley City
Canada · 2 centers
  • GSK Investigational Site — Toronto
  • GSK Investigational Site — Montreal
Japan · 2 centers
  • GSK Investigational Site — Tokyo
  • GSK Investigational Site — Tokyo
South Korea · 2 centers
  • GSK Investigational Site — Seoul
  • GSK Investigational Site — Seoul
Australia · 1 center
  • GSK Investigational Site — Melbourne

Identifiers

NCT: NCT07332455 · 300164 · 2025-523874-17

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗