[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of LB4330 in patients with advanced malignant solid tumors
主要目的:
评价 LB4330 在晚期恶性实体瘤患者中的安全性和耐受性,并探索 LB4330 的最大耐受剂量(MTD),确定Ⅱ期临床试验推荐剂量(RP2D)。
次要目的:
1) 评价 LB4330 在晚期实体瘤患者中的药代动力学(PK)和药效动力学(PD)特征。
2) 评价 LB4330 在晚期实体瘤患者中的免疫原性。
3) 初步评价 LB4330 在晚期实体瘤患者中的抗肿瘤疗效。
4) 初步评价 LB4330 治疗晚期恶性肿瘤患者的疗效相关的生物标志物,为Ⅱ期临床试验的治疗人群选择提供依据。
[Translation] Primary objectives:
To evaluate the safety and tolerability of LB4330 in patients with advanced malignant solid tumors, explore the maximum tolerated dose (MTD) of LB4330, and determine the recommended dose (RP2D) for Phase II clinical trials.
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of LB4330 in patients with advanced solid tumors.
2) To evaluate the immunogenicity of LB4330 in patients with advanced solid tumors.
3) To preliminarily evaluate the anti-tumor efficacy of LB4330 in patients with advanced solid tumors.
4) To preliminarily evaluate the biomarkers related to the efficacy of LB4330 in the treatment of patients with advanced malignant tumors, and provide a basis for the selection of treatment populations for Phase II clinical trials.