To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Adequate bone marrow and other vital organ functions
Adequate liver function tests
Metastatic Castration-resistant Prostate Cancer
Plan to receive any other anti-tumor therapy during the study.
Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
Uncontrolled hypertension (systolic blood pressure [SBP] > 150 mmHg and/or diastolic blood pressure [DBP] > 100 mmHg with regular anti-hypertension therapy).
Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of IP.
Single group
HRS-5041 Single dose of HRS-5041 orally administered
DrugHRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.
Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination
To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.
Concentration
Plasma concentrations of HRS-5041 during multiple dosing, directly observed from data
Cmax,ss
Css, max are steady-state maximum concentrations of HRS-5041during multiple dosing, and are directly observed from data.
Cmin,ss
Css, min are the steady-state trough concentrations of HRS-5041 during multiple dosing, and are directly observed from data
Objective Response Rate (ORR)
ORR refers to the proportion of subjects with a complete response (CR) or partial response (PR) based on all soft tissue assessments recorded from the date of first drug administration to either the date of radiographic disease progression (including bone progression and soft tissue progression), death from any cause, or the initiation of a new antitumor therapy, whichever occurs first. For subjects with CR or PR at the first evaluation, the efficacy should be confirmed 4 weeks later or at the next tumor imaging evaluation. The numerator includes subjects with a confirmed CR/PR at least 4 weeks after the initial assessment. The denominator consists of subjects with measurable target lesions at baseline.
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