OncoMatch/Clinical Trials/NCT07339267
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
Is NCT07339267 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ASP5541 and Prednisone for prostate cancer.
Treatment: ASP5541 · Prednisone — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen deprivation therapy (GnRH analogue) — ongoing or history of bilateral orchiectomy
Participant is receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1).
Cannot have received: systemic ketoconazole, abiraterone acetate, or any CYP17 inhibitor (ketoconazole, abiraterone acetate)
Exception: must have discontinued ≥ 4 weeks prior to first dose
Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.
Cannot have received: strong CYP3A4 inducer or inhibitor
Exception: must have discontinued ≥ 4 weeks prior to first dose
Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.
Cannot have received: biotin (vitamin B7) > 30 μg/day (biotin)
Exception: eligible if switched to ≤ 30 μg/day prior to first dose
Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg/day or less prior to first dose of study drug is eligible for study entry.
Cannot have received: investigational therapy
Exception: within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1
Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.
Cannot have received: ASP5541 (ASP5541)
Participant has received ASP5541 previously.
Lab requirements
Blood counts
absolute neutrophil count ≥ 1500/μL, platelet count ≥ 100000/μL, hemoglobin ≥ 9 g/dL, INR < 1.5 (unless on oral anticoagulants, then INR ≤ 2.0), serum albumin ≥ 3.0 g/dL
Kidney function
calculated creatinine clearance ≥ 30 mL/min
Liver function
No moderate or severe hepatic impairment (Child-Pugh Class B or C); serum total bilirubin ≤ 1.5 x ULN (except Gilbert's disease); ALT/AST ≤ 2.5 x ULN
Cardiac function
No clinically significant cardiac arrhythmias (except rate-controlled atrial fibrillation), no congenital long QT syndrome, QTcF < 450 msec, no NYHA Class III/IV heart failure, LVEF ≥ 50%, no unstable angina or recent MI (within 6 months), no uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg), no recent thrombotic/embolic events (within 3 months except adequately treated catheter-related venous thrombosis > 1 month prior)
See full eligibility for detailed organ function requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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