First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
Recruiting now Phase 1/2 NCT07332455
Run by GlaxoSmithKline · for 18 and older · Men
What this study 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 join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- 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 this trial is running
- 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, Toronto, Ontario, Canada
- GSK Investigational Site, Montreal, Quebec, Canada
- GSK Investigational Site, Tokyo, Japan
- GSK Investigational Site, Tokyo, Japan
- GSK Investigational Site, Seoul, Seoul Teugbyeolsi, South Korea
Who to contact
US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07332455.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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