Testing GSK5471713 in adults with metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first‑in‑human, phase 1/2, open‑label trial gives GSK5471713 as a single agent to adults with metastatic castration‑resistant prostate cancer to define safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity. The study will use dose‑escalation to determine a recommended phase 2 dose and then enroll expansion cohorts to look for early signs of anti‑tumor effect. Eligible participants have histologically confirmed prostate adenocarcinoma, ECOG 0–1, progression on ADT and prior AR pathway inhibitors, and prior taxane chemotherapy as specified. Key exclusions include non‑adenocarcinoma histologies (for example small cell/neuroendocrine), significant cardiac disease, uncontrolled infection or lab abnormalities, and prior AR degrader therapy.

Why it matters

Who can join: the full rules

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 and life expectancy of ≥3 months (≥12 weeks).
* 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. Participants should have received all approved standard-of-care therapies for which they are eligible, including biomarker directed therapy, in accordance with current clinical guidelines, unless a documented contraindication or another justified medical reason precluded their use.

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's running

• GSK Investigational Site
  La Jolla, California, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  Grand Rapids, Michigan, United States Recruiting
• GSK Investigational Site
  Philadelphia, Pennsylvania, United States Recruiting
• GSK Investigational Site
  West Valley City, Utah, United States Recruiting
• GSK Investigational Site
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.