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

Phase 1

Recruiting

• Conditions: Advanced Prostate Cancer
• Interventions: Drug: HRS-5041

• Registration Number: NCT05942001
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-12
• Study Start: 2023-08-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS-5041	HRS-5041	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Up to 28 days
Maximum tolerated dose (MTD)	Up to 28 days
Recommended Phase 2 Dose (RP2D) of HRS-5041	Up to 28 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics - Area under the plasma concentration time curve (AUC)	12 weeks
Pharmacokinetics - Maximum plasma concentration (Cmax)	12 weeks
Pharmacokinetics - Time to Cmax (Tmax)	12 weeks
Overall survival (OS)	24 months
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
Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)	24 months
PSA Progression Free Survival (PFS)	24 months
Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)	24 months
Radiographic progression free survival (rPFS)	24 months

Trial Locations

Locations (1)

Shanghai Jiaotong University School of Medicine, Renji Hospital; 🇨🇳 Shanghai, Shanghai, China