HRS-7525 tablets in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial evaluating the safety and tolerability of HRS-7525 tablets in men with advanced prostate cancer. The study aims to identify dose limiting toxicities, establish the maximum tolerated dose if possible, and determine the recommended Phase II dose for further testing. Eligible participants are adults 18-80 with good performance status and metastatic adenocarcinoma of the prostate, who have not received concurrent anti-tumor therapy during the study. The trial is conducted across sites in Australia, including Sydney and Queensland, led by Jiangsu HengRui Medicine Co., Ltd. The primary focus is to characterize safety and dosing in this initial stage.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily participating in this clinical study, understanding the study procedures, and being able to provide written informed consent;
2. Males, aged 18-80 years (inclusive; no upper age limit in the expansion stage);
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1;
4. Life expectancy ≥12 weeks;
5. Histologically or cytologically confirmed adenocarcinoma of the prostate, without a diagnosis of neuroendocrine carcinoma or small cell carcinoma;
6. Presence of metastatic lesions confirmed by CT/MRI or radionuclide bone scan (99mTc);
7. Male participants with a female partner of childbearing potential must agree to refrain from sperm donation and use appropriate contraceptive measures from the time of signing the informed consent form until 3 months after the last dose of the investigational product；

Exclusion Criteria:

1. Planning to receive any other anti-tumor therapy during this study;
2. Having received chemotherapy, targeted therapy, immunotherapy, live attenuated vaccines, radiotherapy, or surgery, etc., less than 4 weeks prior to the start of study treatment; participating in another clinical study within 4 weeks prior to the start of study treatment (calculated from the last use of the investigational drug);
3. Damage caused by any prior anti-tumor treatment has not recovered to Grade ≤ 1 or the criteria specified in this study (graded according to NCI-CTCAE 6.0; excluding alopecia and other adverse events deemed tolerable by the investigator);
4. Participants with poorly controlled hypertension, and those with a history of hypertensive crisis or hypertensive encephalopathy;
5. Known tumor metastasis to the central nervous system or meningeal metastasis, or participants with a history of primary central nervous system tumor;
6. Severe bone injury caused by tumor bone metastases as judged by the investigator, including poorly controlled severe bone pain, pathological fractures at critical sites and spinal cord compression that have occurred within the last 6 months or are highly likely to occur in the near future;
7. Presence of one of the various factors affecting oral drug administration or active gastrointestinal diseases or other conditions that may significantly affect drug absorption, distribution, metabolism or excretion;
8. Known allergy or intolerance to HRS-7525 or its excipients;
9. Presence of active heart disease or severe cerebrovascular disease within 6 months prior to the first dose of the study, including severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug therapy;
10. Any other malignant tumor within 5 years prior to the first dose in the study (excluding carcinoma in situ that has been completely relieved and malignant tumors that are judged by the investigator as slowly progressive);
11. Presence of active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL), hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection of the analytical method); or participants with severe infections requiring control with antibiotics, antivirals, or antifungals;
12. History of immunodeficiency (including positive HIV test, or other acquired or congenital immunodeficiency disorders) or history of organ transplantation;
13. Presence of other factors that may affect the study results or result in premature discontinuation of this study as judged by the investigator, such as alcoholism, drug abuse, presence of other severe diseases (including mental illness) requiring concomitant treatment, significant laboratory abnormalities, family or social factors, and other conditions that may affect the safety of participants or the collection of study data.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Macquarie University Hospital
  Sydney, New South Wales, Australia Not yet recruiting
• ICON South Brisbane
  Brisbane, Queensland, Australia Not yet recruiting
• John Flynn Private Hospital
  Gold Coast, Queensland, Australia Not yet recruiting
• ICON Kurralta Park
  Adelaide, South Australia, Australia Not yet recruiting
• Southern Oncology Research Uni(SOCRU)
  Adelaide, South Australia, Australia Not yet recruiting

Study contacts

• Study coordinator: Jianpo Lian
• Email: jianpo.lian.jl3@hengrui.com
• Phone: +0518-81220121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.