A Phase Ⅱ Study of F520 in Patients With Urothelial Carcinoma

Phase 2

• Conditions: Locally Advanced or Metastatic Urothelial Cell Carcinoma
• Interventions: Drug: F520

• Registration Number: NCT04636515
• Lead Sponsor: Shandong New Time Pharmaceutical Co., LTD

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-18
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19
• Study Start: 2021-01
• Primary Completion: 2022-03
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	F520	-

Primary Outcome Measures

Name	Time	Method
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