NCT07332455 · GlaxoSmithKline
First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
What this study is about
This first-time-in-human study will evaluate the safety, tolerability, how the drug moves through the body, how the drug affects the body, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a treatment given alone in mCRPC.
View original scientific description
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.
Interventions
DRUG
GSK5471713
GSK5471713 will be administered at different dose levels based on the dose escalation study design
Primary outcome measures
Number of participants with dose limiting toxicities (DLTs)
Time frame: 28 days
Number of participants with adverse events (AEs), and serious adverse events (SAEs)
Time frame: Approximately 45 months
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity
Time frame: Approximately 45 months
Number of participants with AEs leading to dose modifications
Time frame: Approximately 45 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- La Jolla, California
- Grand Rapids, Michigan
- Philadelphia, Pennsylvania
- West Valley City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations