Actively Recruiting
A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-21
100
Participants Needed
2
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study aims to assess the safety and tolerability of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer, and determine the recommended Phase II dose (RP2D); To evaluate of the efficacy of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer based on Prostate-Specific Antigen (PSA) response rate.
CONDITIONS
Official Title
A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 85 years (up to 80 years for dose escalation phase)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected life expectancy of at least 12 weeks
- Prostate-specific antigen (PSA) level of 1 ng/mL or higher during screening
- Receiving luteinizing hormone-releasing hormone analog (LHRHa) therapy or prior bilateral orchiectomy for castration
- Histologically or cytologically confirmed prostate adenocarcinoma (not neuroendocrine or small cell carcinoma)
- Radiographically confirmed metastatic disease by CT/MRI or bone scan
- Male participants with female partners of childbearing potential must use highly effective contraception during and for 5 months after treatment and avoid sperm donation during this time
You will not qualify if you...
- Planning to receive other anti-tumor therapies during the study
- Use of investigational drugs not approved for marketing within 4 weeks before study start
- Recent surgeries requiring general anesthesia within 28 days or minor surgeries within 7 days before starting treatment
- Unresolved adverse events from prior anti-tumor therapy above Grade 1 (except some controlled conditions)
- Known allergy to study drugs or their ingredients
- Untreated or uncontrolled central nervous system (CNS) metastases
- Uncontrolled tumor-related pain or unstable analgesic regimen
- Uncontrolled third-space fluid buildup requiring repeated drainage
- History of other cancers within 5 years except certain treated skin, thyroid, or breast cancers
- History of seizures or conditions leading to seizures within 12 months
- History or evidence of lung diseases like interstitial lung disease or active pneumonia
- Severe gastrointestinal disorders such as obstructions, bleeding, ulcers, or inflammatory bowel diseases
- Recent severe infections or active tuberculosis
- Active hepatitis B or C infection
- History of immunodeficiency, organ transplantation, or active autoimmune disease (with some exceptions)
- Severe cardiovascular or cerebrovascular disease
- Recent arterial or venous blood clots within 3 months or clots detected during screening
- Any other condition that may affect safety or study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
2
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
Research Team
Y
Yue Cheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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