The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
Voluntary consent to participate in the study and signed the informed consent form.
Male or female, age 18-75 years (including both).
Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.
Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
1. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
Single group
Disitamab Vedotin for injection
DrugIntravesical instiliations into the bladder
Incidence of dose-limiting toxicity(DLT) (Phase I)
Incidence of Adverse event (Phase I)
According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade
Recommended Phase II Dose(RP2D)
Assessed based on the Incidence of DLT
Maximum Tolerated Dosage(MTD)
Assessed based on the Incidence of DLT
Disease-free survival (DFS) rates
Disease-free survival (DFS) rates was defined as the time from the date of first study treatment to the time of the subject's first high-grade Ta, T1 of any grade, CIS lasting greater than or equal to 6 months, new carcinoma in situ (CIS), cystectomy, disease progression, or death from any cause
Duration of response (DOR)
Defined as the time from the start of the first assessment of CR to the first assessment of high grade Ta, any grade of T1, new CIS, disease progression, cystectomy, or death from any cause
Disitamab Vedotin anti-drug antibody (ADA)
The number and proportion of anti-drug antibody (ADA)-positive subjects were analyzed according to dose group and time point.
PK of enfortumab vedotin: Maximum concentration (Cmax)
Cmax will be recorded from the PK blood samples collected.
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