Prostate CancerPhase 1/2NCT06568094
A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
A Phase 1/2 study testing HRS-5041 tablets, Abiraterone Acetate tablets（II） and Prednisone Acetate tablets in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HRS-5041 tablets, Abiraterone Acetate tablets（II） and Prednisone 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
- 2 sitesChina
- Study dates
- 25 Sep 2024to Jun 2027
- Phase
- Phase 1/2
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
- Have the ability to give informed consent, and are willing and able to comply with planned visits for medical examinations and other procedural requirements.
- The age is above 18 years old when signing the informed consent (the ceiling age is 80 years old in the dose escalation phase), male.
- ECOG score is 0 or 1.
- An expected survival of ≥ 12 weeks.
- Adenocarcinoma of the prostate confirmed with histologically or cytologically ,and without a diagnosis of neuroendocrine or small cell carcinoma.
- Adequate blood samples should be provided for gene mutation detection during the screening period. It is recommended to provide tumor tissue samples.
- Male subjects whose partner is women of childbearing potential (WOCBP) are required to use highly effective contraception from the date of signing the informed consent until 3 months after the last dose of the investigational drug.
Who cannot join
- Plan to receive any other antitumor therapy during this study.
- Had history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Or had other malignancies in the 5 years prior to the first dose.
- Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter.
- Had undergone major surgery within 28 days prior to first dosing; Minor traumatic surgery within 7 days prior to first dosing; There are non-healing wounds, untreated fractures.
- Drugs with a strong inducer or inhibitor of the metabolic enzyme CYP3A have been used in the past, and the washout period from the end time to the first administration in this study is shorter than the 5 half-life of the drug.
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
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- Central nervous system or meningeal metastasis of tumors is known or subjects have a history of primary central nervous system tumors.
- Severe cerebrovascular disease occurred within 6 months prior to administration.
- Subjects with poorly controlled hypertension and a history of hypertensive crisis or hypertensive encephalopathy.
- Severe bone injury due to bone metastases, pathological fractures , and spinal cord compression as determined by the investigators at important sites that occurred within the last 6 months or are expected to occur in the near future.
- Having one of multiple factors that affect the oral drug or having an active gastrointestinal disease or other disease that may significantly affect drug absorption, distribution, metabolism, or excretion.
- Had history of allergy to the proposed investigational drug or its excipient components.
- Presence of active heart disease in the 6 months prior to first dosing, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias.
- Presence of active hepatitis B and hepatitis C; Or serious infected persons requiring antibiotics, antivirals or antifungal drugs to control.
- Presence of the history of immunodeficiency or organ transplantation.
- Presence of other serious physical or mental diseases or laboratory abnormalities.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Xuedong Li
- Recruiting
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200433
Wei Xue
About this study
Official title: An Open, Multicenter Phase Ib/II Study on the Safety, Tolerability and Efficacy of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- HRS-5041 tablets, Abiraterone Acetate tablets（II）, Prednisone Acetate tablets, Docetaxel Injection, HRS-1167 tablets
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5041 tabletsDrug
HRS-5041 tablets
Abiraterone Acetate tablets（II）Drug
Abiraterone Acetate tablets（II）
Prednisone Acetate tabletsDrug
Prednisone Acetate tablets
Docetaxel InjectionDrug
Docetaxel Injection
HRS-1167 tabletsDrug
HRS-1167 tablets
SHR2554 tabletsDrug
SHR2554 tablets
HRS-6208 capsulesDrug
HRS-6208 capsules
HRS-2189 TabletsDrug
HRS-2189 tablets.
| Study group | Role | What they receive |
|---|---|---|
| HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets | Experimental | Not described Receives: Drug: HRS-5041 tablets; Drug: Abiraterone Acetate tablets（II）; Drug: Prednisone Acetate tablets |
| HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets | Experimental | Not described Receives: Drug: HRS-5041 tablets; Drug: Prednisone Acetate tablets; Drug: Docetaxel Injection |
| HRS-5041 tablets combined with HRS-1167 tablets | Experimental | Not described Receives: Drug: HRS-5041 tablets; Drug: HRS-1167 tablets |
| HRS-5041 tablets combined with SHR2554 tablets | Experimental | Not described Receives: Drug: HRS-5041 tablets; Drug: SHR2554 tablets |
| HRS-5041 tablets combined with HRS-6208 capsules | Experimental | Not described Receives: Drug: HRS-5041 tablets; Drug: HRS-6208 capsules |
| HRS-6208 capsules combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets | Experimental | Not described Receives: Drug: Abiraterone Acetate tablets（II）; Drug: Prednisone Acetate tablets; Drug: HRS-6208 capsules |
| HRS-5041 tablets combined with HRS-2189 tablets | Experimental | Not described Receives: Drug: HRS-5041 tablets; Drug: HRS-2189 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase II dose (Phase Ib)
Measured: 21 or 28 days
Incidence and severity of adverse events (AE) (Phase Ib)
Measured: 2 years
PSA response rate (Phase II)
Measured: 1 year
Secondary outcomes (13)
Objective response rate (ORR)
Measured: 1 year
Disease control rate (DCR)
Measured: 1 year
Duration of response (DoR)
Measured: 1 year
PSA response rate
Measured: 1 year
Time to PSA progression
Measured: 1 year
Radiographic progression-free survival (rPFS)
Measured: 1 year
Overall survival (OS)
Measured: 2 years
Blood concentrations of HRS-5041(Phase Ib)
Measured: 16 weeks
Blood concentrations of HRS-1167(Phase Ib)
Measured: 16 weeks
Blood concentrations of SHR2554(Phase Ib)
Measured: 16 weeks
Blood concentrations of Abiraterone (Phase Ib)
Measured: 16 weeks
Blood concentrations of HRS-6208 (Phase Ib)
Measured: 16 weeks
Blood concentrations of HRS-2189 (Phase Ib)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start25 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- HRS-5041 tablets combined with antitumor therapy
- 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
- NCT06568094
- Sponsor's protocol ID
- HRS-5041-201
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided