To evaluate the safety and efficacy of recombinant anti-PD-L1 monoclonal antibody injection (ZKAB001) combined with Albumin-bound paclitaxel in the treatment of Advanced urothelial carcinoma
This trial is designed to first include 6 subjects to confirm the dose safety. If the toxicity is intolerable, the dose of chemotherapeutic drugs will be reduced depending on the toxicity for further exploration.If it was tolerated, the recommended dose was determined, and the dose was extended. 14 patients were enrolled to further observe the safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
Patients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks .
Beijing Tumor Hospital
Beijing, Beijing Municipality, China
Dose limiting toxicity (DLT)
Adverse events of level 3 or above related to the study drug occurring within 21 days after the first dose as assessed by CTCAE v5.0.
Time frame: 21 days after first dose
Recommended phase II dose (RP2D)
DLT occurs in no more than 1/6 subjects, this dose is defined as RP2D.
Time frame: 21 days after first dose
objective response rate
Percentage of patients in partial and complete response
Time frame: 12 months
progression free survival
time between first dose of study drug to disease progression
Time frame: 12 months
PD-L1 expression
The positive rate of PD-L1 expression in tumor tissue.
Time frame: 12 months
TMB expression
The positive rate of TMB expression in tumor tissue.
Time frame: 12 months
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