[Translation] A multicenter, open-label, dose-escalation and dose-expansion Phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor efficacy of KH003 in patients with advanced solid tumors
主要目的:评估KH003治疗晚期实体瘤的安全性和耐受性,为后期临床试验给药方案提供安全的剂量范围。
次要目的:1)评估KH003在晚期实体瘤患者中的药代动力学特征;2)评估KH003的抗肿瘤疗效;3)评估KH003在晚期实体瘤患者中的免疫原性。
探索性目的:评价患者肿瘤或血液样本中的生物标志物与KH003疗效相关性。
[Translation] Primary objective: To evaluate the safety and tolerability of KH003 in the treatment of advanced solid tumors and provide a safe dosage range for the dosing regimen of later clinical trials.
Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of KH003 in patients with advanced solid tumors; 2) To evaluate the anti-tumor efficacy of KH003; 3) To evaluate the immunogenicity of KH003 in patients with advanced solid tumors.
Exploratory objective: To evaluate the correlation between biomarkers in patient tumor or blood samples and the efficacy of KH003.