Locally Advanced or Metastatic Urothelial Cell Carcinoma
Conditions
Brief summary
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).
Interventions
DRUGF520
200mg，Q3W
Sponsors
Shandong New Time Pharmaceutical Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed,locally advanced（T4b,any N or any T,N2-3 or metastatic carcinoma（including renal pelvic, ureter bladder and urethra）; 2. Cohort 1：Patients with First-line platinum ineligible must meet criteria for either option a or option b (below): 1. 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: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 within 7 days prior to randomization * National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade ≥2 audiometric hearing loss * NCI CTCAE Version 5.0 Grade ≥2 peripheral neuropathy OR 2. In the opinion of the investigator, is considered ineligible to receive any platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on: * ECOG PS of 2 within 7 days prior to randomization. and ≥1 of the following: * Documented visceral metastatic disease * NCI CTCAE Version 5.0 Grade ≥2 audiometric hearing loss * NCI CTCAE Version 5.0 Grade ≥2 peripheral neuropathy 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; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 * Calculated creatinine clearance ≥ 30 milliliter (mL)/min (Cockcroft-Gault formula)
Exclusion criteria
1. Has received prior therapy with an anti-PD-1, anti-PD-L1 agent or with CTLA-4 receptor; 2. Has a known hypersensitivity to anti-PD-1 / PD-L1 agent; 3. Known pia meningeal metastasis or active central nervous system (CNS) metastasis revealed by CT or MRI. Participants with asymptomatic brain metastases may participate without evidence of progression for at least 1 month. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator | Approximately 24 months | ORR is defined as CR+PR |
Outcome results
None listed