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Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer

Primary Purpose

Advanced Prostate Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HRS-4357 injection
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HRS-4357 injection

    Arm Description

    Outcomes

    Primary Outcome Measures

    Prog Dose limiting toxicity (DLT)
    recommended phase 2 dose (RP2D)
    recommended dosing cycle.
    PSA50 response rate

    Secondary Outcome Measures

    Maximum plasma concentration (Cmax)
    time to maximum plasma concentration (Tmax)
    area under the plasma concentration-time curve (AUC)
    clearance (Cl)
    volume of distribution (Vz)
    terminal half-life (t1/2)
    cumulative urinary excretion of radioactive dose
    Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
    PSA90 response rate
    time to PSA progression
    Overall Response Rate (ORR)
    Disease control Rate (DCR)
    Duration of Response (DoR)
    Radiographic Progression-free Survival (rPFS)
    Overall Survival (OS)
    Incidence and severity of AEs and SAEs

    Full Information

    First Posted
    August 8, 2023
    Last Updated
    August 16, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06006104
    Brief Title
    Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer
    Official Title
    A Phase I/II Clinical Study to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-4357 in Patients With PSMA Positive Advanced Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    49 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HRS-4357 injection
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    HRS-4357 injection
    Intervention Description
    HRS-4357 injection
    Primary Outcome Measure Information:
    Title
    Prog Dose limiting toxicity (DLT)
    Time Frame
    up to 9 months follow-up
    Title
    recommended phase 2 dose (RP2D)
    Time Frame
    up to 9 months follow-up
    Title
    recommended dosing cycle.
    Time Frame
    up to 9 months follow-up
    Title
    PSA50 response rate
    Time Frame
    up to 12 weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Maximum plasma concentration (Cmax)
    Time Frame
    up to 6 weeks follow-up
    Title
    time to maximum plasma concentration (Tmax)
    Time Frame
    up to 6 weeks follow-up
    Title
    area under the plasma concentration-time curve (AUC)
    Time Frame
    up to 6 weeks follow-up
    Title
    clearance (Cl)
    Time Frame
    up to 6 weeks follow-up
    Title
    volume of distribution (Vz)
    Time Frame
    up to 6 weeks follow-up
    Title
    terminal half-life (t1/2)
    Time Frame
    up to 6 weeks follow-up
    Title
    cumulative urinary excretion of radioactive dose
    Time Frame
    up to 6 weeks follow-up
    Title
    Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
    Time Frame
    up to 6 weeks follow-up
    Title
    PSA90 response rate
    Time Frame
    up to 12 weeks follow-up]
    Title
    time to PSA progression
    Time Frame
    up to 9 months follow-up
    Title
    Overall Response Rate (ORR)
    Time Frame
    up to 20 months follow-up
    Title
    Disease control Rate (DCR)
    Time Frame
    up to 20 months follow-up
    Title
    Duration of Response (DoR)
    Time Frame
    up to 20 months follow-up
    Title
    Radiographic Progression-free Survival (rPFS)
    Time Frame
    up to 9 months follow-up
    Title
    Overall Survival (OS)
    Time Frame
    up to 20 months follow-up
    Title
    Incidence and severity of AEs and SAEs
    Time Frame
    up to 20 months follow-up

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xueying Zheng
    Phone
    +0518-82342973
    Email
    xueying.zheng.xz17@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer

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