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.
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;
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;
Single group
SHR-2005
DrugIn dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.
Incidence of dose limiting toxicities (DLTs)
Maximum tolerated dose (MTD)
Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)
RP2D（Recommended Phase 2 dose）
PK parameter: Tmax of SHR-2005
Time to maximum concentration of SHR-2005
PK parameter: Cmax of SHR-2005
Maximum concentration of SHR-2005
PK parameter: AUC0-∞ of SHR-2005
area under the concentration-time curve from time 0 to infinity of SHR-2005
Immunogenicity of SHR-2005
Anti- SHR-2005 antibody (ADA)
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