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This is a multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody F520 in participants with locally advanced or metastatic Urothelial Cancer (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F520 | Drug | 200mg,Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator | ORR is defined as CR+PR | Approximately 24 months |
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Inclusion Criteria:
Histologically or cytologically confirmed,locally advanced(T4b,any N or any T,N2-3 or metastatic carcinoma(including renal pelvic, ureter bladder and urethra);
Cohort 1:Patients with First-line platinum ineligible must meet criteria for either option a or option b (below):
Has a tumor(s) with PD-L1 combined positive and is considered ineligible to receive cisplatin-based combination therapy, based on 1 of the following:
In the opinion of the investigator, is considered ineligible to receive any platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on:
Cohort 2: Inoperable Patients in sencond line(or beyond)with locally advanced or metastatic urothelial carcinoma who have disease recurrence or progression during or after a platinum-based chemotherapy regimen;
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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