[Translation] A Phase Ib/II, open-label, dose-escalation and expansion study evaluating LB1410 in combination with LB4330 in patients with advanced/metastatic solid tumors
主要目的:
1.在晚期实体瘤成人患者中,评估LB1410联合LB4330的安全性和耐受性。
2.确定剂量递增阶段LB1410联合LB4330最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。
3.评估LB1410联合LB4330的抗肿瘤疗效。
次要目的:
1.评估LB1410联合LB4330在晚期实体瘤患者中的药代动力学(PK)特征。
2.评价LB1410联合LB4330的免疫原性(ADA)。
3.评价LB1410联合LB4330的ADA与PK、安全性和疗效间的关系。
4.检测基线期采集的肿瘤组织中PD-L1、TIM3、Claudin18.2(按肿瘤类型细分检测项目)。
探索性目的:
?LB1410联合LB4330药效学或潜在生物预测标记物:淋巴细胞亚群(含CD8+ T细胞、CD4+ T细胞等),细胞因子。
[Translation] Primary objectives:
1. To evaluate the safety and tolerability of LB1410 combined with LB4330 in adult patients with advanced solid tumors.
2. To determine the maximum tolerated dose (MTD) and/or the recommended dose (RP2D) of LB1410 combined with LB4330 in the dose escalation phase.
3. To evaluate the anti-tumor efficacy of LB1410 combined with LB4330.
Secondary objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of LB1410 combined with LB4330 in patients with advanced solid tumors.
2. To evaluate the immunogenicity (ADA) of LB1410 combined with LB4330.
3. To evaluate the relationship between ADA and PK, safety and efficacy of LB1410 combined with LB4330.
4. To detect PD-L1, TIM3, and Claudin18.2 in tumor tissues collected at baseline (test items are subdivided by tumor type).
Exploratory objectives:
? Pharmacodynamic or potential biological predictive markers of LB1410 combined with LB4330: lymphocyte subsets (including CD8+ T cells, CD4+ T cells, etc.), cytokines.