Status:
UNKNOWN
Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06006104
Start Date
September 30 2023
End Date
October 31 2024
Last Update
August 23 2023
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