Actively Recruiting
A Study of SHR-4394 Injection in Subjects With Prostate Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-02-27
240
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.
CONDITIONS
Official Title
A Study of SHR-4394 Injection in Subjects With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 85 years
- ECOG physical condition score of 0-1
- Expected survival of 6 months or longer
- Histologically or cytologically confirmed prostate adenocarcinoma
- At least one metastasis lesion present
- Disease progression after the most recent prior treatment
- Receiving continuous luteinizing hormone releasing hormone analogues or previous bilateral orchidectomy
- Testosterone levels at castration range
- Adequate organ function
You will not qualify if you...
- Received systemic anticancer treatments or investigational drugs within 4 weeks before study treatment start
- Unresolved toxicities grade 2 or higher from previous anticancer therapy
- History or symptoms of meningeal or central nervous system metastasis
- Uncontrollable tumor-related pain
- Uncontrolled pleural, pericardial, or abdominal effusion with symptoms
- Other serious concomitant diseases
- Previous or current other malignancies
- History of severe allergic reactions to SHR-4394 or its ingredients
- Active hepatitis B or C infection
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Q
Qi Shi
CONTACT
Y
Yueling Wang
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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