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Trial Title:
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT ID:
NCT05942001
Condition:
Advanced Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
HRS-5041 single arm
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-5041
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.
Arm group label:
HRS-5041
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able and willing to provide a written informed consent.
2. Age 18-80 years old, gender unlimited.
3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1.
4. Predicted survival ≥12 weeks.
5. Histological or cytological confirmed adenocarcinoma of the prostate.
6. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal
therapy.
Exclusion Criteria:
1. Prior treatment with an androgen receptor (AR) degrader.
2. Plan to receive any other antitumor therapy during this trial.
3. Receiving other investigational drugs or treatments that are not on the market
within 4 weeks prior to the initial administration of the study.
4. Patients with known brain metastases.
5. Any significant medical condition, such as uncontrolled infection, laboratory
abnormality, or psychiatric illness.
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Jiaotong University School of Medicine, Renji Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Xue, Doctor
Phone:
021-58752345
Email:
uroxuewei@163.com
Start date:
September 15, 2023
Completion date:
August 31, 2025
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/NCT05942001
