A Phase Ⅱ Study of F520 in Patients With Urothelial Carcinoma

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 2, Open-label, Single-arm，Multicenter Study of F520 in Patients With Urothelial Carcinoma

Conditions
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Locally Advanced or Metastatic Urothelial Cell Carcinoma

Intervention / Treatment
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* Drug: F520


Participation Criteria
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Eligibility Criteria
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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: 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 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: Has received prior therapy with an anti-PD-1, anti-PD-L1 agent or with CTLA-4 receptor; Has a known hypersensitivity to anti-PD-1 / PD-L1 agent; 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/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: F520<br>* 200mg，Q3W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |