Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-5041.
- Who it may be relevant to
- Registry conditions: Advanced Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- 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.
Primary outcome measures
- Dose-limiting toxicity (DLT) [Time frame: Up to 28 days]
- Maximum tolerated dose (MTD) [Time frame: Up to 28 days]
- Recommended Phase 2 Dose (RP2D) of HRS-5041 [Time frame: Up to 28 days]
Secondary outcome measures (9)
- Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria [Time frame: 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) [Time frame: 12 weeks]
- Pharmacokinetics - Maximum plasma concentration (Cmax) [Time frame: 12 weeks]
- Pharmacokinetics - Time to Cmax (Tmax) [Time frame: 12 weeks]
- Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [Time frame: 24 months]
- PSA Progression Free Survival (PFS) [Time frame: 24 months]
- Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) [Time frame: 24 months]
- Radiographic progression free survival (rPFS) [Time frame: 24 months]
- Overall survival (OS) [Time frame: 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Jiaotong University School of Medicine, Renji Hospital — Shanghai
Identifiers
NCT: NCT05942001 · HRS-5041-101