Prostate CancerPhase 1NCT07711184
A Clinical Study of HRS-7525 Tablets in Patients With Advanced Prostate Cancer
A Phase 1 study testing HRS-7525 tablets in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HRS-7525 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 30 Jul 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Who cannot join
- 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;
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- 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 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;
- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Australia6 sites, 6 recruiting
- Not yet recruiting
ICON Kurralta Park
Adelaide, South Australia, 5037
Craig Gedye
- Not yet recruiting
Southern Oncology Research Uni(SOCRU)
Adelaide, South Australia, 5042
Ganessan Kichenadasse
- Not yet recruiting
ICON South Brisbane
Brisbane, Queensland, 4101
Jim Coward
- Not yet recruiting
John Flynn Private Hospital
Gold Coast, Queensland, 4224
David Martin
- Not yet recruiting
Epworth Health
Melbourne, Victoria, 3121
Arun Azad
- Not yet recruiting
Macquarie University Hospital
Sydney, New South Wales, 2109
Alison Zhang
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dingwei Ye
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- HRS-7525 tablets
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7525 tabletsDrug
HRS-7525 tablets
| Study group | Role | What they receive |
|---|---|---|
| HRS-7525 tablets | Experimental | Not described Receives: Drug: HRS-7525 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose limiting toxicity (DLT)
Measured: a single-dose run-in period (2 days) and 21 days after the first administration of each subject
the maximum tolerated dose (MTD)
Measured: 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)
Measured: From the signing of the informed consent to the end of the safety follow-up period of each subject ，about 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start30 Jul 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711184
- Sponsor's protocol ID
- HRS-7525-101
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07711184
- Acronym / sponsor ID
- HRS-7525-101
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-7525 tablets | Experimental | Drug: HRS-7525 tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7525 tabletsHRS-7525 tablets | Drug | HRS-7525 tablets |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-7525 tablets in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianpo Lian (+0518-81220121, jianpo.lian.jl3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.