A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
NCT ID: NCT07230106
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
218 participants
INTERVENTIONAL
2025-11-30
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 Group
HS-20093 for Injection
HS-20093 for injection.
SHR3680 Tablet
SHR3680 tablet.
Abiraterone Tablet
Abiraterone tablet.
Cohort 2 Group
SHR3680 Tablet
SHR3680 tablet.
SHR2554 Tablet
SHR2554 tablet.
Enzalutamide Tablet
Enzalutamide tablet.
Darotamine Capsule
Darotamine capsule.
Interventions
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HS-20093 for Injection
HS-20093 for injection.
SHR3680 Tablet
SHR3680 tablet.
Abiraterone Tablet
Abiraterone tablet.
SHR2554 Tablet
SHR2554 tablet.
Enzalutamide Tablet
Enzalutamide tablet.
Darotamine Capsule
Darotamine capsule.
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 80 years (inclusive), male.
3. ECOG performance status of 0 or 1.
4. Expected survival time ≥12 weeks.
5. Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma.
6. Able to provide sufficient tumor tissue samples for retrospective genetic testing.
7. Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration).
8. PSA level ≥1 ng/ml at screening.
9. Adequate organ function levels at baseline assessment.
10. Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later.
Exclusion Criteria
2. Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0.
3. Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment.
4. Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment.
5. Major surgery within 28 days prior to enrollment; palliative radiotherapy within 14 days prior to enrollment; or traumatic minor surgery within 7 days prior to enrollment.
6. Pathological fractures in critical locations, spinal cord compression, etc., within the recent 6 months.
7. Non-healing wounds, untreated fractures, or severe bone damage due to metastatic disease.
8. Poorly controlled tumor-related pain.
9. Dysphagia or other conditions significantly affecting drug absorption.
10. Known central nervous system metastases or primary brain tumors.
11. Significant pericardial, pleural, or peritoneal effusion requiring intervention.
12. Severe cardiovascular or cerebrovascular diseases.
13. Moderate to severe pulmonary disease significantly affecting respiratory function.
14. Poorly controlled diabetes.
15. Serious active infections within 14 days prior to enrollment.
16. Active Hepatitis B, Hepatitis C, HIV, or immunodeficiency diseases.
17. History of other malignancies within 5 years prior to enrollment.
18. Any other condition deemed by the investigator to potentially affect the study.
18 Years
80 Years
MALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR3680-205
Identifier Type: -
Identifier Source: org_study_id
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