RecruitingPhase 1Phase 2NCT07332455

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

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)


Sponsor

GlaxoSmithKline

Enrollment

54 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new drug called GSK5471713 in men with advanced prostate cancer that has spread (metastatic) and is no longer responding to hormone therapy (castration-resistant prostate cancer, or mCRPC). The study is testing the drug's safety and how it works in the body. **You may be eligible if...** - You have been diagnosed with metastatic castration-resistant prostate cancer (confirmed by biopsy) - Your cancer has continued to grow despite hormone therapy - You have received at least one prior hormone-blocking drug and one to two prior chemotherapy regimens - Your overall health and performance level are good (ECOG 0–1) **You may NOT be eligible if...** - Your prostate cancer is a rare subtype (e.g., small cell or neuroendocrine) - You have significant heart problems - You have an uncontrolled infection or serious abnormal lab values - You have previously received a drug that degrades the androgen receptor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGSK5471713

GSK5471713 will be administered at different dose levels based on the dose escalation study design


Locations(6)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07332455


Related Trials