NCT07711184

Brief 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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
41mo left

Started Jul 2026

Geographic Reach
2 countries

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2029

Study Start

First participant enrolled

July 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 2, 2026

Last Update Submit

July 13, 2026

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

HRS-7525 tablets

EXPERIMENTAL
Drug: HRS-7525 tablets

Interventions

HRS-7525 tabletsDRUG

HRS-7525 tablets

HRS-7525 tablets

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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；

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

Location

ICON South Brisbane

Brisbane, Queensland, 4101, Australia

Location

John Flynn Private Hospital

Gold Coast, Queensland, 4224, Australia

Location

ICON Kurralta Park

Adelaide, South Australia, 5037, Australia

Location

Southern Oncology Research Uni(SOCRU)

Adelaide, South Australia, 5042, Australia

Location

Epworth Health

Melbourne, Victoria, 3121, Australia

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Jianpo Lian

CONTACT

+0518-81220121jianpo.lian.jl3@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 17, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

July 17, 2026

Record last verified: 2026-07

Locations

CN(1)AU(6)