RecruitingPhase 1Phase 2NCT06990880

A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer

A Phase 1/2 First-Time-In-Human, Open-Label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-Cancer Agents in Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Sponsor

GlaxoSmithKline

Enrollment

85 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called GSK5458514, either on its own or combined with other cancer treatments, in men with advanced prostate cancer that has stopped responding to hormone therapy. **You may be eligible if...** - You are male, 18 or older - You have metastatic prostate cancer that no longer responds to hormone therapy (called castration-resistant prostate cancer) - Your cancer has progressed after treatment with newer hormone-blocking drugs and 1–2 rounds of chemotherapy - You are willing to use contraception during the study and for about 6 months after **You may NOT be eligible if...** - You have not received prior treatment with certain hormone-blocking drugs or chemotherapy - You only have rising PSA levels with no visible cancer on scans 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.

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Interventions

DRUGGSK5458514

GSK5458514 will be administered.


Locations(15)

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Lyon, France

GSK Investigational Site

Villejuif, France

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Badajoz, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Pozuelo de AlarcOn Madr, Spain

View Full Details on ClinicalTrials.gov

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NCT06990880


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