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Recruiting Phase 1/2 NCT07332455

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

Phase 1/2 – combined early trial
Conditions: Neoplasms, Prostate

Sponsor: GlaxoSmithKline

trial.available_in: БГ
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.
Who can participate
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.
Interventions
GSK5471713
DRUG
Locations 6
Canada (2)
GSK Investigational Site
Montreal , Quebec
US GSK Clinical Trials Call Center
GSK Investigational Site
Toronto , Ontario
US GSK Clinical Trials Call Center
Japan (1)
GSK Investigational Site
Tokyo
US GSK Clinical Trials Call Center
United States (3)
GSK Investigational Site
Grand Rapids , Michigan
US GSK Clinical Trials Call Center
GSK Investigational Site
Philadelphia , Pennsylvania
US GSK Clinical Trials Call Center
GSK Investigational Site
West Valley City , Utah
US GSK Clinical Trials Call Center
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
10.02.2026
Completion date
26.03.2030
Registry ID
NCT07332455
Source
clinicaltrials.gov
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