[Translation] A non-randomized, open-label, multicenter Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LY01019 injection in patients with advanced solid tumors
主要目的:
在晚期实体瘤患者中评估LY01019注射液的安全性和耐受性,观察剂量限制性毒性(DLT),探索最大耐受剂量(MTD),并确定II期临床试验推荐剂量(RP2D)。
次要目的:
在晚期实体瘤患者及各瘤种适应症队列中评价LY01019注射液的药代动力学特征(PK)、免疫原性及初步疗效。
探索目的:
(1)观察LY01019注射液暴露量与受体占位关系,给药后全血中T细胞表面PD-L1受体占位率(RO)和血液中TGF-β1浓度;
(2)探索肿瘤组织PD-L1表达与LY01019注射液抗肿瘤活性相关性;探索机体外周血免疫细胞状态与LY01019注射液抗肿瘤活性相关性。
[Translation] Primary objective:
To evaluate the safety and tolerability of LY01019 injection in patients with advanced solid tumors, observe dose-limiting toxicity (DLT), explore the maximum tolerated dose (MTD), and determine the recommended dose (RP2D) for phase II clinical trials.
Secondary objective:
To evaluate the pharmacokinetic characteristics (PK), immunogenicity and preliminary efficacy of LY01019 injection in patients with advanced solid tumors and various tumor indication cohorts.
Exploratory objectives:
(1) To observe the relationship between the exposure of LY01019 injection and receptor occupancy, the PD-L1 receptor occupancy rate (RO) on the surface of T cells in whole blood after administration, and the concentration of TGF-β1 in blood;
(2) To explore the correlation between PD-L1 expression in tumor tissue and the anti-tumor activity of LY01019 injection; to explore the correlation between the state of peripheral blood immune cells and the anti-tumor activity of LY01019 injection.