[Translation] A multicenter, randomized, open-label phase II/III clinical trial comparing the efficacy and safety of LB1410 in combination with lenvatinib, or without LB4330, versus investigator-selected chemotherapy in patients with advanced recurrent/metastatic cervical cancer.
主要目的:评估LB1410联合仑伐替尼(±LB4330)的抗肿瘤疗效。
次要目的:(1)评估LB1410联合仑伐替尼(±LB4330)的安全性和耐受性。(2)评价LB1410联合仑伐替尼(±LB4330)的无进展生存期(PFS),总生存期(OS)和疾病控制率(DCR)。(3)评价LB1410的免疫原性(ADA)。(4)评价LB1410的药代动力学特征。
探索性目的:(1)探索TIM3和PD-L1表达对LB1410联合仑伐替尼(±LB4330)疗效的影响。(2)探索LB4330的药效动力学特征:外周血特异性免疫细胞因子(包括但不限于IL-18、IFN-γ),及其与联合LB4330疗效之间的相关性。
[Translation] Primary Objective: To evaluate the antitumor efficacy of LB1410 in combination with lenvatinib (±LB4330).
Secondary Objectives: (1) To evaluate the safety and tolerability of LB1410 in combination with lenvatinib (±LB4330). (2) To evaluate the progression-free survival (PFS), overall survival (OS), and disease control rate (DCR) of LB1410 in combination with lenvatinib (±LB4330). (3) To evaluate the immunogenicity (ADA) of LB1410. (4) To evaluate the pharmacokinetic characteristics of LB1410.
Exploratory Objectives: (1) To explore the effects of TIM3 and PD-L1 expression on the efficacy of LB1410 in combination with lenvatinib (±LB4330). (2) To explore the pharmacodynamic characteristics of LB4330: peripheral blood-specific immune cytokines (including but not limited to IL-18 and IFN-γ), and their correlation with the efficacy of LB4330 in combination.