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Trial Title:
Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer
NCT ID:
NCT06006104
Condition:
Advanced Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-4357 injection
Description:
HRS-4357 injection
Arm group label:
HRS-4357 injection
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 30, 2023
Completion date:
October 31, 2024
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06006104
