Actively Recruiting
A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-08-26
102
Participants Needed
2
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).
CONDITIONS
Official Title
A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed malignant tumor
- Failed standard therapy, intolerant to standard therapy, or no standard treatment available
- Adequate organ function
- Voluntary participation with ability to provide written informed consent
- Expected survival of at least 12 weeks
- Measurable lesions required for dose-expansion phase
- Agreement to use contraception from consent through 60 days after last dose
You will not qualify if you...
- Prior treatment with the same class of investigational drug
- Confirmed or suspected central nervous system tumor involvement
- Uncontrolled tumor-related pain
- Active autoimmune disease or history of immunodeficiency including HIV
- Clinically significant cardiovascular disease history
- Known hypersensitivity to investigational drug components
- Major surgery or significant trauma within 4 weeks before first dose
- Diagnostic or superficial surgery within 7 days before first dose
- Planned major surgery during the study
- Adverse events from prior therapy not recovered to CTCAE Grade 1 or better
- Severe infection within 4 weeks or active infection within 2 weeks before first dose
- History of cerebrovascular accident within 6 months before first dose
- Other active malignancies within 2 years prior or concurrent malignancies
- Any other condition making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
2
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
J
Jie Shen
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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