Advanced Prostate CancerPhase 1NCT05942001
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
A Phase 1 study testing HRS-5041, Docetaxel injection and Abiraterone acetate tablets in people with Advanced Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- HRS-5041, Docetaxel injection and Abiraterone acetate tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2023to Sep 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality
Wei Xue, Doctor, 021-58752345, uroxuewei@163.com
About this study
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
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.
- Conditions
- Advanced Prostate Cancer
- Being tested
- HRS-5041, Docetaxel injection, Abiraterone acetate tablets, Prednisone Acetate Tablets, Enzalutamide Soft Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5041Drug
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.
Docetaxel injectionDrug
Docetaxel injection.
Abiraterone acetate tabletsDrug
Abiraterone Acetate tablets.
Prednisone Acetate TabletsDrug
Prednisone Acetate tablets.
Enzalutamide Soft CapsulesDrug
Enzalutamide Soft capsules.
| Study group | Role | What they receive |
|---|---|---|
| HRS-5041 | Experimental | Not described Receives: Drug: HRS-5041 |
| Docetaxel Injection + Prednisone Acetate Tablets group | Active comparator | Not described Receives: Drug: Docetaxel injection; Drug: Prednisone Acetate Tablets |
| Abiraterone Acetate Tablets + Prednisone Acetate Tablets group | Active comparator | Not described Receives: Drug: Abiraterone acetate tablets; Drug: Prednisone Acetate Tablets |
| Enzalutamide Soft Capsules group | Active comparator | Not described Receives: Drug: Enzalutamide Soft Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: Up to 28 days
Maximum tolerated dose (MTD)
Measured: Up to 28 days
Recommended Phase 2 Dose (RP2D) of HRS-5041
Measured: Up to 28 days
Secondary outcomes (9)
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
Measured: 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)
Measured: 12 weeks
Pharmacokinetics - Maximum plasma concentration (Cmax)
Measured: 12 weeks
Pharmacokinetics - Time to Cmax (Tmax)
Measured: 12 weeks
Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
Measured: 24 months
PSA Progression Free Survival (PFS)
Measured: 24 months
Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Measured: 24 months
Radiographic progression free survival (rPFS)
Measured: 24 months
Overall survival (OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start3 Aug 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HRS-5041 single arm
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942001
- Sponsor's protocol ID
- HRS-5041-101
- Status last verified
- Aug 2026
- First submitted
- 5 Jul 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided