The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.
To evaluate the preliminary efficacy of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC.
Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
Age ≥ 18 years old, gender is not limited;
Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
Expected survival time ≥ 2 years;
Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration;
Intravesical instillation of cytotoxic chemotherapy or other drugs;
Immune checkpoint inhibitor;
Other investigational products for the treatment of NMIBC.
Single group
SHR-1501
DrugSHR-1501 single agent dose escalation, and in combination of BCG or SHR-1316.
Dose-limiting toxicity
Maximum tolerated dose
Recommended Phase 2 dose (RP2D)
CR Rate (cohort 2)
Treatment-Related Adverse Events as assessed by CTCAE v5.0
Duration of CR (DoR)
CR rate at 6 months and 18 months
DFS
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