NCT06226350

A Phase Ⅱ Study of F520 in Patients With Cervical Carcinoma

An Open, Single-arm, Multicenter Phase II Trial of Efficacy and Safety of F520 Monotherapy in the Treatment of Advanced, Persistent, Recurrent, or Metastatic Cervical Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was an open, single-arm, enriched, multicenter Phase II study.

Detailed description

The trial was divided into screening period, treatment period and follow-up period. Participants entered the screening period after signing informed consent and met the inclusion criteria. Subjects who did not meet the exclusion criteria were treated with F520 monotherapy, intravenously, at 3mg/kg every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection	F520,IV, 3mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons.

Timeline

• Start date: 2021-03-04
• Primary completion: 2023-12-05
• Completion: 2024-01-03
• First posted: 2024-01-26
• Last updated: 2024-01-26

Locations

1 site across 1 country: China