A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
• ≥18 years of age, either sex;
• Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
• ECOG performance status of 0-1;
• Life expectancy ≥ 2 years;
• Adequate bone marrow and organ function.
Locations
Other Locations
China
Fudan University Zhongshan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Shouwei Zhao
shouwei.zhao@hengrui.com
0518-82342973
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 170
Treatments
Experimental: SHR-2005
Only one arm with SHR-2005
Related Therapeutic Areas
Sponsors
Leads: Shanghai Hengrui Pharmaceutical Co., Ltd.