Advanced Prostate Cancer
Conditions
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.
Interventions
DRUGHRS-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.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HRS-5041 single arm
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Radiographic progression free survival (rPFS) | 24 months |
| Overall survival (OS) | 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 |
| Pharmacokinetics - Area under the plasma concentration time curve (AUC) | 12 weeks |
| Pharmacokinetics - Maximum plasma concentration (Cmax) | 12 weeks |
Countries
China
Contacts
Primary ContactSuyu Fan
Outcome results
None listed