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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Conditions
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Advanced Prostate Cancer

Intervention / Treatment
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* Drug: HRS-5041


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: HRS-5041 single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRS-5041<br> | Drug: HRS-5041<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Overall survival (OS) |  | 24 months |