This is a single-center, single-arm, phase Ib/II study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) which is not completely resectable by transurethral resection of bladder tumor (TURBt).
Age ≥18 years old, both genders
Previous pathological biopsy was diagnosed as high-risk NMIBC
Tumors cannot be completely resected by TURBT（at least 2 senior urologists assessed that the lesion area is too extensive to be completely resected）
Ineligible or unwilling to undergo radical cystectomy
Previous pathological biopsy was diagnosed with muscle-invasive bladder cancer at T2 or higher stages
Received any other intravesical chemotherapy treatment within 2 weeks or received any other clinical drugs within 4 weeks
History of allergy to any of the study drugs or study drug components
Upper urinary tract tumor detected by CTU or MRU during screening period or other concomitant malignant tumors within 5 years before the first administration
Single group
SHR-1501+SHR-2005
DrugSHR-1501, instillation；SHR-2005, instillation
Phase I : Incidence of dose limiting toxicities (DLTs)
Phase I : RP2D（Recommended Phase 2 dose）
Phase I : Incidence and severity of adverse events (AEs)
Phase II : CR rate at 3 months
Phase I : CR rate at 3 months
Phase II : Incidence and severity of adverse events (AEs)
Phase Ib/II: PR rate at 3 months
Phase Ib/II: CR rate at 6 months and 12months
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This trial is not recruiting at the moment. You can still explore other options:
