First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
Recruiting · NCT07332455 · Interventional (participants receive a specific treatment) · Lead sponsor: GlaxoSmithKline
View the official record on ClinicalTrials.gov →Interventions studied
GSK5471713
What this trial is about
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 take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
11 locations listed across 4 US states.
- GSK Investigational Site - La Jolla, California, United States
- GSK Investigational Site - Grand Rapids, Michigan, United States
- GSK Investigational Site - Philadelphia, Pennsylvania, United States
- GSK Investigational Site - West Valley City, Utah, United States
- GSK Investigational Site - Seoul, South Korea
- GSK Investigational Site - Tokyo, Japan
- GSK Investigational Site - Tokyo, Japan
- GSK Investigational Site - Toronto, Ontario, Canada
- GSK Investigational Site - Montreal, Quebec, Canada
- GSK Investigational Site - Seoul, Seoul Teugbyeolsi, South Korea
- GSK Investigational Site - Melbourne, Victoria, Australia