Actively Recruiting
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-12-03
170
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
CONDITIONS
Official Title
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older, any sex
- Diagnosed with intermediate or high-risk non-muscle invasive bladder cancer by biopsy
- ECOG performance status of 0 or 1
- Life expectancy of at least 2 years
- Adequate bone marrow and organ function
You will not qualify if you...
- Received bladder surgery or radiotherapy within 2 weeks before first dose
- Currently in another clinical trial or less than 4 weeks since ending another trial
- History of serious cardiovascular or cerebrovascular diseases
- Severe infection within 2 weeks before first dose
- Unresolved adverse reactions from previous anti-tumor treatments above Grade 1
- Major surgery or severe trauma within 4 weeks before first dose
- Prior treatment with any TNFR agonist antibody therapy such as OX40, CD137, CD27, or CD357 antibodies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Shouwei Zhao
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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