The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
HRS-5041 was given oral administration, qd, at a 28-day cycle. Patients may continue to use HRS-5041 until disease progression or unacceptable toxicity occurs.
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDose-limiting toxicity (DLT)
Time frame: Up to 28 days
Maximum tolerated dose (MTD)
Time frame: Up to 28 days
Recommended Phase 2 Dose (RP2D) of HRS-5041
Time frame: Up to 28 days
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
Time frame: From the time of consent at screening until 30 days after the subject discontinues study treatment, up to 2 years
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
Time frame: 12 weeks
Pharmacokinetics - Maximum plasma concentration (Cmax)
Time frame: 12 weeks
Pharmacokinetics - Time to Cmax (Tmax)
Time frame: 12 weeks
Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Time frame: 24 months
PSA Progression Free Survival (PFS)
Time frame: 24 months
Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Time frame: 24 months
Radiographic progression free survival (rPFS)
Time frame: 24 months
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Overall survival (OS)
Time frame: 24 months