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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer

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

A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer (NCT06568094) is a Phase 1 / Phase 2 interventional studying Prostate Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Prostate Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Prostate Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Have the ability to give willing to sign a consent form, and are willing and able to comply with planned visits for medical examinations and other procedural requirements. 2. The age is above 18 years old when signing the willing to sign a consent form (the ceiling age is 80 years old in the dose escalation phase), male. 3. ECOG score is 0 or 1. 4. An expected survival of ≥ 12 weeks. 5. Adenocarcinoma of the prostate confirmed with histologically or cytologically ,and without a diagnosis of neuroendocrine or small cell carcinoma. 6. Adequate blood samples should be provided for gene mutation detection during the screening period. It is recommended to provide tumor tissue samples. 7. Male subjects whose partner is women of childbearing potential (WOCBP) are required to use highly effective contraception from the date of signing the willing to sign a consent form until 3 months after the last dose of the investigational drug. Who Should NOT Join This Trial: 1. Plan to receive any other antitumor therapy during this study. 2. Had history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Or had other malignancies in the 5 years prior to the first dose. 3. 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. 4. 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. 5. Drugs with a strong inducer or inhibitor of the metabolic enzyme CYP3A have been used in the past, and the waiting period after previous treatment from the end time to the first administration in this study is shorter than the 5 half-life of the drug. 6. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Have the ability to give informed consent, and are willing and able to comply with planned visits for medical examinations and other procedural requirements. 2. 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. 3. ECOG score is 0 or 1. 4. An expected survival of ≥ 12 weeks. 5. Adenocarcinoma of the prostate confirmed with histologically or cytologically ,and without a diagnosis of neuroendocrine or small cell carcinoma. 6. Adequate blood samples should be provided for gene mutation detection during the screening period. It is recommended to provide tumor tissue samples. 7. 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. Exclusion Criteria: 1. Plan to receive any other antitumor therapy during this study. 2. Had history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Or had other malignancies in the 5 years prior to the first dose. 3. 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. 4. 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. 5. 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. 6. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I. 7. Central nervous system or meningeal metastasis of tumors is known or subjects have a history of primary central nervous system tumors. 8. Severe cerebrovascular disease occurred within 6 months prior to administration. 9. Subjects with poorly controlled hypertension and a history of hypertensive crisis or hypertensive encephalopathy. 10. 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. 11. 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. 12. Had history of allergy to the proposed investigational drug or its excipient components. 13. 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. 14. Presence of active hepatitis B and hepatitis C; Or serious infected persons requiring antibiotics, antivirals or antifungal drugs to control. 15. Presence of the history of immunodeficiency or organ transplantation. 16. Presence of other serious physical or mental diseases or laboratory abnormalities.

Treatments Being Tested

DRUG

HRS-5041 tablets

HRS-5041 tablets

DRUG

Abiraterone Acetate tablets(II)

Abiraterone Acetate tablets(II)

DRUG

Prednisone Acetate tablets

Prednisone Acetate tablets

DRUG

Docetaxel Injection

Docetaxel Injection

DRUG

HRS-1167 tablets

HRS-1167 tablets

DRUG

SHR2554 tablets

SHR2554 tablets

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06568094), the sponsor (Jiangsu HengRui Medicine Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06568094 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06568094?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06568094?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06568094. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06568094. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.