Actively Recruiting
A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-03-03
218
Participants Needed
2
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.
CONDITIONS
Official Title
A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 80 years
- Willing to participate and able to provide written informed consent
- ECOG performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
- Able to provide sufficient tumor tissue samples for genetic testing
- Receiving continuous androgen deprivation therapy during the study
- PSA level of at least 1 ng/ml at screening
- Adequate organ function at baseline
- Male participants with female partners of childbearing potential must agree to avoid sperm donation and use effective contraception during and after treatment as specified
You will not qualify if you...
- Known hypersensitivity or intolerance to study drugs or their ingredients
- Unresolved adverse events from prior anti-tumor therapy not improved to Grade 1 or less
- Use of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days before enrollment
- Use of herbal medicines with anti-prostate cancer or PSA-lowering effects within 14 days before enrollment
- Major surgery within 28 days or palliative radiotherapy within 14 days before enrollment
- Pathological fractures in critical areas or spinal cord compression within 6 months
- Non-healing wounds, untreated fractures, or severe bone damage from metastasis
- Poorly controlled tumor-related pain
- Conditions significantly affecting drug absorption such as dysphagia
- Known brain tumors or central nervous system metastases
- Significant fluid buildup requiring intervention
- Severe cardiovascular, cerebrovascular, or pulmonary diseases
- Poorly controlled diabetes
- Active serious infections or immunodeficiency diseases
- Active Hepatitis B, Hepatitis C, or HIV
- History of other cancers within 5 years
- Any other condition affecting study participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
2
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
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Research Team
W
Wenliang Wang
CONTACT
Q
Qi Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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