> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-of-hrs-7525-tablets-in-patients-with-293008f0-6ccf-44f9-91ea-da6694513b02 > Record changed: 2026-10-13 # A Clinical Study of HRS-7525 Tablets in Patients With Advanced Prostate Cancer NCT07711184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) Lead sponsor Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) Start date 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) Number of sites 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Title and summary **Summary** The purpose of this study is to evaluate the safety and tolerability of HRS-7525 in participants with Advanced Prostate Cancer, and to determine the dose limiting toxicity (DLT), the maximum tolerated dose (MTD, if possible), and the recommended Phase II dose (RP2D) of HRS-7525. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Short title** A Clinical Study of HRS-7525 Tablets in Patients With Advanced Prostate Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Official title** A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-7525 Tablets in Patients With Advanced Prostate Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Dates **Completion date** 2029-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **First posted** 2026-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Registry last updated** 2026-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Primary completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Start date** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Number of sites** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Lead sponsor** Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Identifiers **Registry ID** NCT07711184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **ClinicalTrials.gov ID** NCT07711184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Outcomes ### Primary outcomes 1. dose limiting toxicity (DLT) Timeframe: a single-dose run-in period (2 days) and 21 days after the first administration of each subject 2. the maximum tolerated dose (MTD) Timeframe: From the signing of the informed consent to the end of the safety follow-up period of each subject ，about 13 months 3. the recommended Phase II dose (RP2D) Timeframe: From the signing of the informed consent to the end of the safety follow-up period of each subject ，about 13 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### 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 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Sites - Macquarie University HospitalSydney, AustraliaNot yet recruiting - ICON South BrisbaneBrisbane, AustraliaNot yet recruiting - John Flynn Private HospitalGold Coast, AustraliaNot yet recruiting - ICON Kurralta ParkAdelaide, AustraliaNot yet recruiting - Southern Oncology Research Uni(SOCRU)Adelaide, AustraliaNot yet recruiting - Epworth HealthMelbourne, AustraliaNot yet recruiting - Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07711184) ## Related records ### Drugs (1) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md) ### Lead sponsors (1) - [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md) ### Conditions (1) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Primary condition ### Targets (1) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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