Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer
Phase 1
Not yet recruiting
- Conditions
- Advanced Prostate Cancer
- Interventions
- Drug: HRS-4357 injection
- Registration Number
- NCT06006104
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 49
Inclusion Criteria
- Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
- Male, age ≥18 years;
- ECOG score 0 - 1;
- Histologically and/or cytologically confirmed adenocarcinoma of the prostate;
Exclusion Criteria
- Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.
- 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.
- Active syphilis infection.
- Known hypersensitivity to components of the study drug or its analogues.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HRS-4357 injection HRS-4357 injection -
- Primary Outcome Measures
Name Time Method Prog Dose limiting toxicity (DLT) up to 9 months follow-up PSA50 response rate up to 12 weeks follow-up recommended dosing cycle. up to 9 months follow-up recommended phase 2 dose (RP2D) up to 9 months follow-up
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) up to 20 months follow-up time to PSA progression up to 9 months follow-up time to maximum plasma concentration (Tmax) 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 cumulative urinary excretion of radioactive dose up to 6 weeks follow-up Radiographic Progression-free Survival (rPFS) up to 9 months follow-up volume of distribution (Vz) 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 Maximum plasma concentration (Cmax) 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 terminal half-life (t1/2) up to 6 weeks follow-up Overall Survival (OS) up to 20 months follow-up PSA90 response rate up to 12 weeks follow-up] Incidence and severity of AEs and SAEs up to 20 months follow-up