NCT07332455PHASE1, PHASE2Recruiting
First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
GlaxoSmithKline
Start Date
2/10/2026
Completion Date
3/26/2030
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 Criteria
Age Range: 18 years to No maximum
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
DRUG
GSK5471713
Conditions
Neoplasms, Prostate
Locations
GSK Investigational Site
La Jolla, California 92093
United States
GSK Investigational Site
Grand Rapids, Michigan 49546
United States
GSK Investigational Site
Philadelphia, Pennsylvania 19107
United States
GSK Investigational Site
West Valley City, Utah 84119
United States
GSK Investigational Site
Melbourne, Victoria 3000
Australia
GSK Investigational Site
Toronto, Ontario M5G 2M9
Canada
GSK Investigational Site
Montreal, Quebec H4A 3J1
Canada
GSK Investigational Site
Tokyo, 104-0045
Japan
GSK Investigational Site
Tokyo, 135-8550
Japan
GSK Investigational Site
Seoul, Seoul Teugbyeolsi 06351
South Korea
GSK Investigational Site
Seoul, 120-752
South Korea