Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Uterine Cervical Neoplasms

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m\^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m\^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

Placebo, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m\^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m\^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

SG001 injection

Bevacizumab injection

SG001 placebo

Fenglin She, MSc

Lingying Wu, M.D

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.

The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.

The primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).

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)

A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer

Incidence and grade of the TRAE、SAE and irAE

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Recurrent, or M...	SG001 injection Paclitaxel Cisplatin Carboplatin Bevacizumab inj... SG001 placebo	18 Years - 70 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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	Recurrent, or M...	SG001 injection Paclitaxel Cisplatin Carboplatin Bevacizumab inj... SG001 placebo	18 Years - 70 Years	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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