The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
HRS-4357 injection
Prog Dose limiting toxicity (DLT)
Time frame: up to 9 months follow-up
recommended phase 2 dose (RP2D)
Time frame: up to 9 months follow-up
recommended dosing cycle.
Time frame: up to 9 months follow-up
PSA50 response rate
Time frame: up to 12 weeks follow-up
Maximum plasma concentration (Cmax)
Time frame: up to 6 weeks follow-up
time to maximum plasma concentration (Tmax)
Time frame: up to 6 weeks follow-up
area under the plasma concentration-time curve (AUC)
Time frame: up to 6 weeks follow-up
clearance (Cl)
Time frame: up to 6 weeks follow-up
volume of distribution (Vz)
Time frame: up to 6 weeks follow-up
terminal half-life (t1/2)
Time frame: up to 6 weeks follow-up
cumulative urinary excretion of radioactive dose
Time frame: up to 6 weeks follow-up
Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 6 weeks follow-up
PSA90 response rate
Time frame: up to 12 weeks follow-up]
time to PSA progression
Time frame: up to 9 months follow-up
Overall Response Rate (ORR)
Time frame: up to 20 months follow-up
Disease control Rate (DCR)
Time frame: up to 20 months follow-up
Duration of Response (DoR)
Time frame: up to 20 months follow-up
Radiographic Progression-free Survival (rPFS)
Time frame: up to 9 months follow-up
Overall Survival (OS)
Time frame: up to 20 months follow-up
Incidence and severity of AEs and SAEs
Time frame: up to 20 months follow-up