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

Advanced Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942001
• Other study ID #: HRS-5041-101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Prostatic Neoplasms

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