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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06006104
Other study ID # HRS-4357-101
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 30, 2023
Est. completion date October 31, 2024

Study information

Verified date August 2023
Source Jiangsu HengRui Medicine Co., Ltd.
Contact Xueying Zheng
Phone +0518-82342973
Email xueying.zheng.xz17@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 49
Est. completion date October 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HRS-4357 injection
HRS-4357 injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Prog Dose limiting toxicity (DLT) up to 9 months follow-up
Primary recommended phase 2 dose (RP2D) up to 9 months follow-up
Primary recommended dosing cycle. up to 9 months follow-up
Primary PSA50 response rate up to 12 weeks follow-up
Secondary Maximum plasma concentration (Cmax) up to 6 weeks follow-up
Secondary time to maximum plasma concentration (Tmax) up to 6 weeks follow-up
Secondary area under the plasma concentration-time curve (AUC) up to 6 weeks follow-up
Secondary clearance (Cl) up to 6 weeks follow-up
Secondary volume of distribution (Vz) up to 6 weeks follow-up
Secondary terminal half-life (t1/2) up to 6 weeks follow-up
Secondary cumulative urinary excretion of radioactive dose up to 6 weeks follow-up
Secondary Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs; up to 6 weeks follow-up
Secondary PSA90 response rate up to 12 weeks follow-up]
Secondary time to PSA progression up to 9 months follow-up
Secondary Overall Response Rate (ORR) up to 20 months follow-up
Secondary Disease control Rate (DCR) up to 20 months follow-up
Secondary Duration of Response (DoR) up to 20 months follow-up
Secondary Radiographic Progression-free Survival (rPFS) up to 9 months follow-up
Secondary Overall Survival (OS) up to 20 months follow-up
Secondary Incidence and severity of AEs and SAEs up to 20 months follow-up
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