Status:
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)
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
- Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
- History of serious cardiovascular and cerebrovascular diseases;
- Severe infection within 2 weeks prior to the first dose;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
- Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;
- Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06108492
Start Date
November 28 2023
End Date
September 30 2027
Last Update
December 3 2024
Active Locations (1)
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1
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032