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

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

Overview

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.

Interventions

• Drug HRS-7525 tablets
  HRS-7525 tablets

Primary outcome measures

• dose limiting toxicity (DLT) [Time frame: a single-dose run-in period (2 days) and 21 days after the first administration of each subject]
• the maximum tolerated dose (MTD) [Time frame: 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) [Time frame: From the signing of the informed consent to the end of the safety follow-up period of each subject ，about 13 months]

Eligibility criteria

Inclusion criteria

• Voluntarily participating in this clinical study, understanding the study procedures, and being able to provide written informed consent;
• Males, aged 18-80 years (inclusive; no upper age limit in the expansion stage);
• Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1;
• Life expectancy ≥12 weeks;
• Histologically or cytologically confirmed adenocarcinoma of the prostate, without a diagnosis of neuroendocrine carcinoma or small cell carcinoma;
• Presence of metastatic lesions confirmed by CT/MRI or radionuclide bone scan (99mTc);
• 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

• Planning to receive any other anti-tumor therapy during this study;
• 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);
• 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);
• Participants with poorly controlled hypertension, and those with a history of hypertensive crisis or hypertensive encephalopathy;
• Known tumor metastasis to the central nervous system or meningeal metastasis, or participants with a history of primary central nervous system tumor;
• 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;
• 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;
• Known allergy or intolerance to HRS-7525 or its excipients;
• 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;
• 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);
• 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;
• History of immunodeficiency (including positive HIV test, or other acquired or congenital immunodeficiency disorders) or history of organ transplantation;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Australia · 6 centers

• Macquarie University Hospital — Sydney
• ICON South Brisbane — Brisbane
• John Flynn Private Hospital — Gold Coast
• ICON Kurralta Park — Adelaide
• Southern Oncology Research Uni(SOCRU) — Adelaide
• Epworth Health — Melbourne

China · 1 center

• Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07711184 · HRS-7525-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗