A Clinical Study of HRS-7525 Tablets in Patients With Advanced Prostate Cancer

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-7525 Tablets in Patients With Advanced Prostate Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: HRS-7525 tablets

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jianpo Lian; Phone Number: +0518-81220121; Email: jianpo.lian.jl3@hengrui.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2109
      • Not yet recruiting
      • Macquarie University Hospital
      • Principal Investigator: Alison Zhang
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Not yet recruiting
      • ICON South Brisbane
      • Principal Investigator: Jim Coward
    • Gold Coast, Queensland, Australia, 4224
      • Not yet recruiting
      • John Flynn Private Hospital
      • Principal Investigator: David Martin
  • South Australia
    • Adelaide, South Australia, Australia, 5037
      • Not yet recruiting
      • ICON Kurralta Park
      • Principal Investigator: Craig Gedye
    • Adelaide, South Australia, Australia, 5042
      • Not yet recruiting
      • Southern Oncology Research Uni(SOCRU)
      • Principal Investigator: Ganessan Kichenadasse
  • Victoria
    • Melbourne, Victoria, Australia, 3121
      • Not yet recruiting
      • Epworth Health
      • Principal Investigator: Arun Azad
• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Principal Investigator: Dingwei Ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-7525 tablets	Drug: HRS-7525 tablets; HRS-7525 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
dose limiting toxicity (DLT)	a single-dose run-in period (2 days) and 21 days after the first administration of each subject
the maximum tolerated dose (MTD)	From the signing of the informed consent to the end of the safety follow-up period of each subject ，about 13 months
the recommended Phase II dose (RP2D)	From the signing of the informed consent to the end of the safety follow-up period of each subject ，about 13 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HRS-7525-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No