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Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Primary Purpose

Advanced Prostate Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HRS-5041
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 - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Able and willing to provide a written informed consent. Age 18-80 years old, gender unlimited. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1. Predicted survival ≥12 weeks. Histological or cytological confirmed adenocarcinoma of the prostate. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy. Exclusion Criteria: Prior treatment with an androgen receptor (AR) degrader. Plan to receive any other antitumor therapy during this trial. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study. Patients with known brain metastases. Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HRS-5041

    Arm Description

    Outcomes

    Primary Outcome Measures

    Dose-limiting toxicity (DLT)
    Maximum tolerated dose (MTD)
    Recommended Phase 2 Dose (RP2D) of HRS-5041

    Secondary Outcome Measures

    Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
    Pharmacokinetics - Area under the plasma concentration time curve (AUC)
    Pharmacokinetics - Maximum plasma concentration (Cmax)
    Pharmacokinetics - Time to Cmax (Tmax)
    Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
    PSA Progression Free Survival (PFS)
    Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
    Radiographic progression free survival (rPFS)
    Overall survival (OS)

    Full Information

    First Posted
    July 5, 2023
    Last Updated
    July 5, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05942001
    Brief Title
    Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
    Official Title
    A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 7, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    August 31, 2025 (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 purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.

    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
    Interventional Study Model
    Single Group Assignment
    Model Description
    HRS-5041 single arm
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HRS-5041
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    HRS-5041
    Intervention Description
    HRS-5041 was given oral administration, qd, at a 28-day cycle. Patients may continue to use HRS-5041 until disease progression or unacceptable toxicity occurs.
    Primary Outcome Measure Information:
    Title
    Dose-limiting toxicity (DLT)
    Time Frame
    Up to 28 days
    Title
    Maximum tolerated dose (MTD)
    Time Frame
    Up to 28 days
    Title
    Recommended Phase 2 Dose (RP2D) of HRS-5041
    Time Frame
    Up to 28 days
    Secondary Outcome Measure Information:
    Title
    Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
    Time Frame
    From the time of consent at screening until 30 days after the subject discontinues study treatment, up to 2 years
    Title
    Pharmacokinetics - Area under the plasma concentration time curve (AUC)
    Time Frame
    12 weeks
    Title
    Pharmacokinetics - Maximum plasma concentration (Cmax)
    Time Frame
    12 weeks
    Title
    Pharmacokinetics - Time to Cmax (Tmax)
    Time Frame
    12 weeks
    Title
    Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
    Time Frame
    24 months
    Title
    PSA Progression Free Survival (PFS)
    Time Frame
    24 months
    Title
    Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
    Time Frame
    24 months
    Title
    Radiographic progression free survival (rPFS)
    Time Frame
    24 months
    Title
    Overall survival (OS)
    Time Frame
    24 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able and willing to provide a written informed consent. Age 18-80 years old, gender unlimited. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1. Predicted survival ≥12 weeks. Histological or cytological confirmed adenocarcinoma of the prostate. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy. Exclusion Criteria: Prior treatment with an androgen receptor (AR) degrader. Plan to receive any other antitumor therapy during this trial. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study. Patients with known brain metastases. Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fei Luo
    Phone
    +0518-81220121
    Email
    fei.luo@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

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