NCT06568094 A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
| NCT ID | NCT06568094 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-09-25 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06568094 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06568094 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06568094 currently recruiting?
Yes, NCT06568094 is actively recruiting participants. Contact the research team at jianpo.lian.jl3@hengrui.com for enrollment information.
Where is the NCT06568094 trial being conducted?
This trial is being conducted at Harbin, China, Shanghai, China.
Who is sponsoring the NCT06568094 clinical trial?
NCT06568094 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 100 participants.
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