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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts 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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

GSK Investigational Site
La Jolla, California 92093
Contact:
US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

GSK Investigational Site
Grand Rapids, Michigan 49546
Contact:
US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

GSK Investigational Site
Philadelphia, Pennsylvania 19107
Contact:
US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

GSK Investigational Site
West Valley City, Utah 84119
Contact:
US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

More Details

Status
Recruiting
Sponsor
GlaxoSmithKline

Study Contact

US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.