RecruitingPhase 1NCT07339267

A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of ASP5541 in Chinese Participants With Advanced Prostate Cancer

Sponsor

Astellas Pharma Global Development, Inc.

Enrollment

12 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

In this study, ASP5541 will be given to Chinese men with prostate cancer. It will be given together with prednisone and androgen deprivation therapy (ADT). Prednisone is a steroid, and ADT is already given to the men as their standard of care for prostate cancer. The main aims of the study are to check the safety of ASP5541, when given with prednisone and ADT, and to check how ASP5541 moves through the bodies of Chinese men. The men will receive ASP5541 as an injection into a muscle (intramuscular injection) at the side of the hip. They will all receive the same dose of ASP5541. The men will be given prednisone and ADT according to their label. The men will continue to receive ASP5541 with prednisone and ADT until their cancer gets worse or the doctor decides the men should stop study treatment.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and drug levels (pharmacokinetics) of a prostate cancer drug called ASP5541 specifically in Chinese patients with prostate cancer that has spread (metastatic disease), either in its hormone-sensitive or castration-resistant form. **You may be eligible if...** - You are a man with confirmed prostate cancer that has spread (metastatic) - Your cancer is either hormone-sensitive (responding to hormone-lowering therapy) or castration-resistant (no longer responding) - You are currently receiving hormone deprivation therapy or have had surgical removal of the testicles - Your cancer has been confirmed on bone scan, CT, MRI, or PSMA PET scan - You are in good physical condition (ECOG 0–1, or ECOG 2 only if due to bone pain) - Your life expectancy is at least 6–12 months **You may NOT be eligible if...** - You have other serious active health conditions - Your cancer is of a specific rare type (neuroendocrine or small cell) - You do not meet the study's laboratory or health criteria 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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