drugset
drugset / Trial / NCT05715840

Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

NCT05715840 ↗

Phase 3 Unknown 368 enrolled CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.

Timeline

Start
2023-01-31
Primary completion
2024-07-31
Completion
2026-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Enlonstobart Monoclonal antibody 360 mg Intravenous
Background Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified 50 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous

Indications

No indication recorded.