Advanced Prostate Cancer
Conditions
Brief summary
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.
Interventions
HRS-4357 injection
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing; 2. Male, age ≥18 years; 3. ECOG score 0 - 1; 4. Histologically and/or cytologically confirmed adenocarcinoma of the prostate;
Exclusion criteria
1. Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression. 2. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study. 3. Active syphilis infection. 4. Known hypersensitivity to components of the study drug or its analogues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prog Dose limiting toxicity (DLT) | up to 9 months follow-up |
| recommended phase 2 dose (RP2D) | up to 9 months follow-up |
| recommended dosing cycle. | up to 9 months follow-up |
| PSA50 response rate | up to 12 weeks follow-up |
Secondary
| Measure | Time frame |
|---|---|
| volume of distribution (Vz) | up to 6 weeks follow-up |
| terminal half-life (t1/2) | up to 6 weeks follow-up |
| cumulative urinary excretion of radioactive dose | up to 6 weeks follow-up |
| Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs; | up to 6 weeks follow-up |
| PSA90 response rate | up to 12 weeks follow-up] |
| time to PSA progression | up to 9 months follow-up |
| Maximum plasma concentration (Cmax) | up to 6 weeks follow-up |
| Disease control Rate (DCR) | up to 20 months follow-up |
| Duration of Response (DoR) | up to 20 months follow-up |
| Radiographic Progression-free Survival (rPFS) | up to 9 months follow-up |
| Overall Survival (OS) | up to 20 months follow-up |
| Incidence and severity of AEs and SAEs | up to 20 months follow-up |
| Overall Response Rate (ORR) | up to 20 months follow-up |
| time to maximum plasma concentration (Tmax) | up to 6 weeks follow-up |
| area under the plasma concentration-time curve (AUC) | up to 6 weeks follow-up |
| clearance (Cl) | up to 6 weeks follow-up |
Contacts
Primary ContactXueying Zheng
Outcome results
None listed