A Phase Ⅱ Study of F520 in Patients With Urothelial Carcinoma

NCT04636515 | Unknown Phase 2

• 1 other identifier: NTP-F520-006
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Locally Advanced or Metastatic Urothelial Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: F520

Interventions

F520 DRUG

200mg，Q3W

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 19, 2020
• Study Start: January 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 19, 2020

Record last verified: 2020-11