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
This is a single-arm, multicenter phase I/II clinical study 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Intravesical instiliations into the bladder
Sun Yat-sen Memorial Hospital,SunYat-sen University
Guangzhou, Guangdong, China
RECRUITINGTongji Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGHunan Cancer hospital
Changsha, Hunan, China
Incidence of dose-limiting toxicity(DLT) (Phase I)
Time frame: Approximately 21 days
Incidence of Adverse event (Phase I)
According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade
Time frame: Approximately 1 years
Recommended Phase II Dose(RP2D)
Assessed based on the Incidence of DLT
Time frame: Approximately 21 days
Maximum Tolerated Dosage(MTD)
Assessed based on the Incidence of DLT
Time frame: Approximately 21 days
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
Time frame: Up to approximately 2 years
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
Time frame: Up to approximately 2 years
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.
Time frame: Up to approximately 2 years
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The first affiliated hospital with nanjing medical universtity
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGWest China Hospital
Chengdu, Sichuan, China
NOT_YET_RECRUITINGTianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITINGPK of enfortumab vedotin: Maximum concentration (Cmax)
Cmax will be recorded from the PK blood samples collected.
Time frame: Approximately 1 years
PK of enfortumab vedotin: Trough concentration (Ctrough)
Ctrough will be recorded from the PK blood samples collected.
Time frame: Approximately 1 year