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

NCT07332455 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 3001642025-523874-17
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Neoplasms, Prostate

Keywords

Metastatic castration-resistant prostate cancer; First-Time-in-Human; GSK5471713; Prostate cancer

Outcome Measures

Primary Outcomes (4)

• Number of participants with dose limiting toxicities (DLTs)

  28 days

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

  Approximately 45 months

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

  Approximately 45 months

• Number of participants with AEs leading to dose modifications

  Approximately 45 months

Secondary Outcomes (5)

• Maximum plasma concentration (Cmax) of GSK5471713

  Approximately 45 months

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

  Approximately 45 months

• Time to maximum plasma concentration (Tmax) of GSK5471713

  Approximately 45 months

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

  Approximately 45 months

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

  Approximately 45 months

Study Arms (1)

Participants receiving GSK5471713

EXPERIMENTAL

Participants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.

Drug: GSK5471713

Interventions

GSK5471713 DRUG

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

Participants receiving GSK5471713

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Grand Rapids, Michigan, 49546, United States

RECRUITING

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

GSK Investigational Site

West Valley City, Utah, 84119, United States

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

GSK Investigational Site

Tokyo, 135-8550, Japan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 12, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): March 24, 2028
• Study Completion (Estimated): March 26, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CA (2); US (3); JP (1)