[Translation] An open-label, multicenter phase I clinical trial evaluating the safety, tolerability, and human pharmacokinetics of ASKG315 for injection in patients with locally advanced or metastatic malignant solid tumors
主要目的
1、评价注射用ASKG315在局部晚期或转移性恶性实体瘤受试者中的安全性和耐受性;
次要目的
1、评价ASKG315(总ASKG315和激活后的ASKG315)的药代动力学特征;
2、评价ASKG315的免疫原性;
3、评价注射用ASKG315的初步抗肿瘤疗效,确定临床Ⅱ期推荐剂量(RP2D)。
探索性目的
1、探索与疗效、作用机制相关的生物标志物。
[Translation] main purpose
1. To evaluate the safety and tolerability of ASKG315 for injection in subjects with locally advanced or metastatic malignant solid tumors;
secondary purpose
1. To evaluate the pharmacokinetic characteristics of ASKG315 (total ASKG315 and activated ASKG315);
2. To evaluate the immunogenicity of ASKG315;
3. To evaluate the preliminary anti-tumor efficacy of ASKG315 for injection, and to determine the recommended dose of clinical phase II (RP2D).
exploratory purpose
1. Explore biomarkers related to efficacy and mechanism of action.