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Clinical Trials in Australia / NCT07332455
Recruiting Phase 1/2

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

NCT07332455 · tracked via the Priya Life Science Australia tracker
Sponsor
GlaxoSmithKline
Phase
Phase 1/2
Started
2026-02-10
Last updated
2026-09-16

Condition(s) studied

Neoplasms, Prostate

Investigational drug(s) / intervention(s)

GSK5471713

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

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (16)

FacilityCityRegionStatus
GSK Investigational Site La Jolla California Recruiting
GSK Investigational Site Grand Rapids Michigan Recruiting
GSK Investigational Site Philadelphia Pennsylvania Recruiting
GSK Investigational Site West Valley City Utah Recruiting
GSK Investigational Site Melbourne Victoria Recruiting
GSK Investigational Site Toronto Ontario Recruiting
GSK Investigational Site Montreal Quebec Recruiting
GSK Investigational Site Montreal Quebec Recruiting
GSK Investigational Site Montpellier France Recruiting
GSK Investigational Site Tokyo Japan Recruiting
GSK Investigational Site Tokyo Japan Recruiting
GSK Investigational Site Amsterdam Netherlands Recruiting
GSK Investigational Site Nijmegen Netherlands Recruiting
GSK Investigational Site Seoul Seoul Teugbyeolsi Recruiting
GSK Investigational Site Seoul South Korea Recruiting
GSK Investigational Site Logroño Spain Recruiting

More GlaxoSmithKline trials in Australia

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A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors Recruiting
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial Active, not recruiting
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults Active, not recruiting
A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01) Recruiting

Other trials for the same condition

A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302] Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07332455 on ClinicalTrials.gov ↗ ← All trials in Australia