NCT04886700

Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer

A Single-arm, Open-label, Multicenter, Phase II Study for Evaluation of Efficacy and Safety of the SG001 Injection for Patients With PD-L1-positive Relapsed or Metastatic Uterine Cervical Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open, single-arm, multicenter phase II study to investigate the efficacy and safety of SG001 for relapsed or metastatic uterine cervical cancer patients with PD-L1 positive (CPS≧1), and has failed at least first line platinum-based chemotherapy.

Detailed description

Phase II: open, single-arm, multicenter.

Conditions

• Uterine Cervical Cancer

Interventions

Type	Name	Description
DRUG	SG001	Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until disease progression, unacceptable toxicity, meeting the suspension or termination criteria, or up to 24 months in patients without disease progression.

Timeline

• Start date: 2021-07-31
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-05-14
• Last updated: 2021-11-22

Locations

1 site across 1 country: China