About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SHR-2005