Back to search results

First-Time-in-Human Study of GSK5471713 for Metastatic Castration-Resistant Prostate Cancer

This study is testing a new targeted therapy called GSK5471713 for the first time in adults with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and is no longer responding to standard hormone therapy. The main goals are to see how safe GSK5471713 is, how well your body tolerates it, and if it shows any early signs of helping to treat the cancer. Researchers will be looking for side effects and how your body handles the drug. You may be eligible if you are an adult male with mCRPC that has progressed on androgen deprivation therapy (ADT) and have a good general health status (ECOG PS 0 or 1). The current recruitment status is unclear.

Study design
This is a first-time-in-human study, meaning GSK5471713 is being tested in people for the first time. It plans to enroll 54 adult male participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track side effects for approximately 45 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07332455

First-Time-in-Human Study of GSK5471713 in Adults With mCRPC

Recruiting
PHASE1Ages 18+InterventionalTreatment
GlaxoSmithKline
~54 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:GSK5471713

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose limiting toxicities (DLTs)
Measured over 28 days
+3 more outcomes measured

Conditions

Neoplasms, Prostate

Explore related trials

Prostate Carcinoma

Where it's being run

11 sites across 10 states
Japan2
California1
Michigan1
Pennsylvania1
Utah1
Victoria1
Ontario1
Quebec1

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with dose limiting toxicities (DLTs)28 days
  • Number of participants with adverse events (AEs), and serious adverse events (SAEs)Approximately 45 months
  • Number of participants with adverse events (AEs), and serious adverse events (SAEs) by SeverityApproximately 45 months
  • Number of participants with AEs leading to dose modificationsApproximately 45 months