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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05942001
Other study ID # HRS-5041-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 15, 2023
Est. completion date August 31, 2025

Study information

Verified date October 2023
Source Jiangsu HengRui Medicine Co., Ltd.
Contact Fei Luo
Phone +0518-81220121
Email fei.luo@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HRS-5041
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.

Locations

Country Name City State
China Shanghai Jiaotong University School of Medicine, Renji Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity (DLT) Up to 28 days
Primary Maximum tolerated dose (MTD) Up to 28 days
Primary Recommended Phase 2 Dose (RP2D) of HRS-5041 Up to 28 days
Secondary Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria From the time of consent at screening until 30 days after the subject discontinues study treatment, up to 2 years
Secondary Pharmacokinetics - Area under the plasma concentration time curve (AUC) 12 weeks
Secondary Pharmacokinetics - Maximum plasma concentration (Cmax) 12 weeks
Secondary Pharmacokinetics - Time to Cmax (Tmax) 12 weeks
Secondary Prostate Specific Antigen (PSA) decline of = 50% from baseline (PSA50) 24 months
Secondary PSA Progression Free Survival (PFS) 24 months
Secondary Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) 24 months
Secondary Radiographic progression free survival (rPFS) 24 months
Secondary Overall survival (OS) 24 months
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