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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
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

  • 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.
Show all 16Show fewer
  • 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.

Jianpo Lian contact

+0518-81220121

jianpo.lian.jl3@hengrui.com

China2 sites, 2 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

    Recruiting

Other trials in China

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 groups in NCT06568094
Study groupRoleWhat they receive
HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tabletsExperimentalNot 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 tabletsExperimentalNot described
Receives: Drug: HRS-5041 tablets; Drug: Prednisone Acetate tablets; Drug: Docetaxel Injection
HRS-5041 tablets combined with HRS-1167 tabletsExperimentalNot described
Receives: Drug: HRS-5041 tablets; Drug: HRS-1167 tablets
HRS-5041 tablets combined with SHR2554 tabletsExperimentalNot described
Receives: Drug: HRS-5041 tablets; Drug: SHR2554 tablets
HRS-5041 tablets combined with HRS-6208 capsulesExperimentalNot described
Receives: Drug: HRS-5041 tablets; Drug: HRS-6208 capsules
HRS-6208 capsules combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tabletsExperimentalNot described
Receives: Drug: Abiraterone Acetate tablets（II）; Drug: Prednisone Acetate tablets; Drug: HRS-6208 capsules
HRS-5041 tablets combined with HRS-2189 tabletsExperimentalNot 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.

  1. Recommended phase II dose (Phase Ib)

    Measured: 21 or 28 days

  2. Incidence and severity of adverse events (AE) (Phase Ib)

    Measured: 2 years

  3. PSA response rate (Phase II)

    Measured: 1 year

Secondary outcomes (13)

  1. Objective response rate (ORR)

    Measured: 1 year

  2. Disease control rate (DCR)

    Measured: 1 year

  3. Duration of response (DoR)

    Measured: 1 year

  4. PSA response rate

    Measured: 1 year

  5. Time to PSA progression

    Measured: 1 year

  6. Radiographic progression-free survival (rPFS)

    Measured: 1 year

  7. Overall survival (OS)

    Measured: 2 years

  8. Blood concentrations of HRS-5041(Phase Ib)

    Measured: 16 weeks

  9. Blood concentrations of HRS-1167(Phase Ib)

    Measured: 16 weeks

  10. Blood concentrations of SHR2554(Phase Ib)

    Measured: 16 weeks

  11. Blood concentrations of Abiraterone (Phase Ib)

    Measured: 16 weeks

  12. Blood concentrations of HRS-6208 (Phase Ib)

    Measured: 16 weeks

  13. 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.

  1. First posted23 Aug 2024
  2. Study start25 Sep 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 7 inclusion and 16 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jianpo Lian (+0518-81220121, jianpo.lian.jl3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase II dose (Phase Ib) (time frame: 21 or 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?

On the ClinicalTrials.gov record for NCT06568094.

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 17 Sep 2026.

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