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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05942001
- Acronym / sponsor ID
- HRS-5041-101
- Conditions
- Advanced Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- HRS-5041 single arm
| Arm | Type | Receives |
|---|---|---|
| HRS-5041 | Experimental | Drug: HRS-5041 |
| Docetaxel Injection + Prednisone Acetate Tablets group | Active comparator | Drug: Docetaxel injection, Drug: Prednisone Acetate Tablets |
| Abiraterone Acetate Tablets + Prednisone Acetate Tablets group | Active comparator | Drug: Abiraterone acetate tablets, Drug: Prednisone Acetate Tablets |
| Enzalutamide Soft Capsules group | Active comparator | Drug: Enzalutamide Soft Capsules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-5041HRS-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. | Drug | HRS-5041 |
| Docetaxel injectionDocetaxel injection. | Drug | Docetaxel Injection + Prednisone Acetate Tablets group |
| Abiraterone acetate tabletsAbiraterone Acetate tablets. | Drug | Abiraterone Acetate Tablets + Prednisone Acetate Tablets group |
| Prednisone Acetate TabletsPrednisone Acetate tablets. | Drug | Abiraterone Acetate Tablets + Prednisone Acetate Tablets group, Docetaxel Injection + Prednisone Acetate Tablets group |
| Enzalutamide Soft CapsulesEnzalutamide Soft capsules. | Drug | Enzalutamide Soft Capsules group |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suyu Fan (+0518-81220121, suyu.fan@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.