A Multicenter, Randomized, Open-Label Phase II/III Clinical Study on the Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 Versus Investigator's Choice of Chemotherapy in Advanced Recurrent/Metastatic Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) assessed by an Independent Radiology Review Committee (IRRC)
研究概览
简要总结
This is a multicenter, randomized, open-label Phase II/III clinical study, aiming to evaluate the efficacy and safety of LB1410 in combination with lenvatinib (whether in combination with LB4330）versus the chemotherapy regimen selected by the investigators for patients with advanced recurrent/metastatic cervical cancer.
详细描述
This study is an open-label, multicenter Phase II/III clinical trial in advanced/metastatic cervical cancer to evaluate the antitumor efficacy, safety, tolerability, pharmacokinetics (PK), and biomarkers of LB1410 in combination with lenvatinib, with or without LB4330.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 3: LB1410
LB1410 (IV, Q2W for up to 2 years)
干预措施: LB1410 (Biological)
Cohort 1: LB1410 + Lenvatinib
LB1410 (intravenous, Q2W) with lenvatinib (oral, QD),up to 2 years
干预措施: LB1410 (Biological)
Cohort 1: LB1410 + Lenvatinib
LB1410 (intravenous, Q2W) with lenvatinib (oral, QD),up to 2 years
干预措施: Lenvatinib (Drug)
Cohort 2: LB1410 + LB4330 + Lenvatinib
LB1410 (IV, Q2W for up to 2 years), LB4330 (IV, Q2W for 4 cycles), and lenvatinib (oral, once daily for up to 2 years)
干预措施: LB1410 (Biological)
Cohort 2: LB1410 + LB4330 + Lenvatinib
LB1410 (IV, Q2W for up to 2 years), LB4330 (IV, Q2W for 4 cycles), and lenvatinib (oral, once daily for up to 2 years)
干预措施: LB4330 (Biological)
Cohort 2: LB1410 + LB4330 + Lenvatinib
LB1410 (IV, Q2W for up to 2 years), LB4330 (IV, Q2W for 4 cycles), and lenvatinib (oral, once daily for up to 2 years)
干预措施: Lenvatinib (Drug)
Cohort 4: LB1410 + LB4330
LB1410 (IV, Q2W for up to 2 years) plus LB4330 (IV, Q2W for 4 cycles)
干预措施: LB1410 (Biological)
Cohort 4: LB1410 + LB4330
LB1410 (IV, Q2W for up to 2 years) plus LB4330 (IV, Q2W for 4 cycles)
干预措施: LB4330 (Biological)
结局指标
主要结局
Objective Response Rate (ORR) assessed by an Independent Radiology Review Committee (IRRC)
时间窗: Approximately 24 months
defined as the percentage of patients with a best overall response of Complete Response or Partial Response per RECIST 1.1.
Duration of Response (DOR) assessed by an Independent Radiology Review Committee (IRRC)
时间窗: Approximately 24 months
defined as the time from the first documented response (CR or PR) to the first documented disease progression or death due to underlying cancer per RECIST 1.1.
次要结局
- Objective Response Rate (ORR) assessed by the investigator(Approximately 24 months)
- Duration of Response (DOR) assessed by the investigator(Approximately 24 months)
- Disease Control Rate (DCR)(Approximately 24 months)
- Progression-Free Survival (PFS)(Approximately 24 months)
- Overall Survival (OS)(Until participant death/end of study,approximately 24 months)
- Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)(From the first dose administration to 30 days after the last dose)
- ADA Antibody Positivity Rate of LB1410(From the first dose administration to 30 days after the last dose)
- Pharmacokinetic (PK) parameters of LB1410-Maximum (peak) Plasma Concentration（Cmax）(From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days))
- Pharmacokinetic (PK) parameters of LB1410-Trough Concentration（Ctrough）(From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days))
- Pharmacokinetic (PK) parameters of LB1410-Area Under the Curve at Steady State(AUCss)(From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days))