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

April 21, 2026 updated by: GlaxoSmithKline

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Srikala Sridhar
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramy Saleh
  • Japan
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuji Miura
  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emerson Lim
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kevin Zarrabi
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Pacheco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receiving GSK5471713
Participants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.
Drug: GSK5471713
GSK5471713 will be administered at different dose levels based on the dose escalation study design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with dose limiting toxicities (DLTs)
Time Frame: 28 days
28 days
Number of participants with adverse events (AEs), and serious adverse events (SAEs)
Time Frame: Approximately 45 months
Approximately 45 months
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity
Time Frame: Approximately 45 months
Approximately 45 months
Number of participants with AEs leading to dose modifications
Time Frame: Approximately 45 months
Approximately 45 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of GSK5471713
Time Frame: Approximately 45 months
Approximately 45 months
Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713
Time Frame: Approximately 45 months
Approximately 45 months
Time to maximum plasma concentration (Tmax) of GSK5471713
Time Frame: Approximately 45 months
Approximately 45 months
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.
Approximately 45 months
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.
Approximately 45 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

March 24, 2028

Study Completion (Estimated)

March 26, 2030

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300164
  • 2025-523874-17 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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