ClinicalTrials.gg
RecruitingNCT07711184Updated Sep 24, 2026

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

A Phase 1 interventional study of HRS-7525 tablets in Prostate Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Recruiting at 7 sites in 2 countries. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.

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Phase
Phase 1
Study type
Interventional
Enrollment
320
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 31 studies in Prostatic Neoplasms by Jiangsu HengRui Medicine Co., Ltd. — 14 open to participants now, 17 under way, 4 of them phase 3. Prostatic Neoplasms · Jiangsu HengRui Medicine Co., Ltd..

Planned enrollment
5th of 31
320 · median 69
Started
2026
with 3 others
Phase 1
14 of 31
6 open now
Primary completion
2028-06
later than 15 of 16 live
Registered
30th of 31
by date

Among the 31 studies in Prostatic Neoplasms by Jiangsu HengRui Medicine Co., Ltd., this one is the 5th largest by planned enrollment, is one of 4 that started in 2026, is one of 14 in phase 1, reaches primary completion later than 15 of the 16 other live ones, and was the 30th registered.

Prostatic Neoplasms

7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

14 of the 31 studies in Prostatic Neoplasms by Jiangsu HengRui Medicine Co., Ltd. are open now, in 2 countries. Recruiting first, the newest first:

8 more — sign in →

By country, each count listing its studies:

All 14 open studies →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years to 80 Years · male · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 31 studies in Prostatic Neoplasms by Jiangsu HengRui Medicine Co., Ltd., or all of them as a file.
02

Study 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.

03

Conditions studied

  • Prostate Cancer

Browse trials for

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily participating in this clinical study, understanding the study procedures, and being able to provide written ;
  2. Males, aged 18-80 years (inclusive; no upper age limit in the expansion stage);
  3. (ECOG) Performance Status score 0-1;
  4. ≥12 weeks;
  5. or cytologically confirmed adenocarcinoma of the prostate, without a diagnosis of neuroendocrine carcinoma or small cell carcinoma;
  6. Presence of lesions confirmed by CT/MRI or radionuclide bone scan (99mTc);
  7. Male participants with a female partner of must agree to refrain from sperm donation and use appropriate measures from the time of signing the informed consent form until 3 months after the last dose of the product;

Exclusion criteria

Exclusion Criteria:

  1. Planning to receive any other anti-tumor therapy during this study;
  2. Having received chemotherapy, targeted therapy, immunotherapy, , 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 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 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 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 ;
  9. 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;
  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 (HBsAg positive and HBV DNA ≥ 500 IU/mL), (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 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.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    HRS-7525 tablets

    Drug: HRS-7525 tablets

Interventions

  • DrugHRS-7525 tablets

    HRS-7525 tablets

06

What researchers measure

Primary outcomes

  1. dose limiting toxicity (DLT)

    Time frame: a single-dose run-in period (2 days) and 21 days after the first administration of each subject

  2. 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

  3. 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

07

Study locations

1 of 7 sites recruiting
  • Macquarie University Hospital
    Sydney, New South Wales 2109, Australia
    Not yet recruiting
    • Alison Zhang · Principal investigator
  • ICON South Brisbane
    Brisbane, Queensland 4101, Australia
    Not yet recruiting
    • Jim Coward · Principal investigator
  • John Flynn Private Hospital
    Gold Coast, Queensland 4224, Australia
    Not yet recruiting
    • David Martin · Principal investigator
  • ICON Kurralta Park
    Adelaide, South Australia 5037, Australia
    Not yet recruiting
    • Craig Gedye · Principal investigator
  • Southern Oncology Research Uni(SOCRU)
    Adelaide, South Australia 5042, Australia
    Not yet recruiting
    • Ganessan Kichenadasse · Principal investigator
  • Epworth Health
    Melbourne, Victoria 3121, Australia
    Not yet recruiting
    • Arun Azad · Principal investigator
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
    • Dingwei Ye · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.

Of 212 industry-sponsored phase 1 interventional studies under Prostatic Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 23 months is below that.

Counting every sponsor, half of 456 studies reached it within 43 months; a quarter within 23 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2026
First posted
Jul 17, 2026
StartActual
Jul 30, 2026
Primary completionEst.
Jun 2028
CompletionEst.
Dec 2029
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07711184
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Jul 30, 2026
Primary completion
Jun 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 24, 2026

Study contacts

Jianpo Lian
Contact
jianpo.lian.jl3@hengrui.com
+0518-81220121

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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