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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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

  • Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

Interventions

DRUG

SG001 injection

360 mg，Q3W，IV infusion

DRUG

Paclitaxel

175 mg/m\^2，Q3W，IV infusion

DRUG

Cisplatin

50 mg/m\^2，Q3W，IV infusion

DRUG

Carboplatin

AUC=5，Q3W，IV infusion

DRUG

Bevacizumab injection

15 mg/kg，Q3W，IV infusion

DRUG

SG001 placebo

Q3W，IV infusion

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lingying Wu, M.D · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05715840 on ClinicalTrials.gov