A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT04603846|
Recruitment Status : Active, not recruiting
First Posted : October 27, 2020
Last Update Posted : January 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Urothelial Carcinoma||Drug: anti-PD-L1 antibody Drug: albumin bound paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma|
|Actual Study Start Date :||September 10, 2020|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||August 25, 2023|
Experimental: Combined treatment group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 6 cycles of albumin-bound paclitaxel 260mg/m2 d1，q3w；
Drug: anti-PD-L1 antibody
Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
Other Name: ZKAB001
Drug: albumin bound paclitaxel
Patients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks .
Other Name: ABRAXANE
- Dose limiting toxicity (DLT) [ Time Frame: 21 days after first dose ]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.
- Recommended phase II dose (RP2D) [ Time Frame: 21 days after first dose ]DLT occurs in no more than 1/6 subjects, this dose is defined as RP2D.
- objective response rate [ Time Frame: 12 months ]Percentage of patients in partial and complete response
- progression free survival [ Time Frame: 12 months ]time between first dose of study drug to disease progression
- PD-L1 expression [ Time Frame: 12 months ]The positive rate of PD-L1 expression in tumor tissue.
- TMB expression [ Time Frame: 12 months ]The positive rate of TMB expression in tumor tissue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603846
|Beijing Tumor Hospital|
|Beijing, Beijing, China, 100000|