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Recruiting Phase 1, Phase 2 NCT06990880

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

Trial Parameters

Condition Neoplasms, Prostate
Sponsor GlaxoSmithKline
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 85
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2025-06-12
Completion 2027-10-26
Interventions
GSK5458514

Brief 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 Criteria

Inclusion Criteria: * Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Male participants ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 195 days, after the last dose of study intervention: Refrain from donating sperm PLUS either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR Must agree to use contraception as detailed below: Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexu

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