[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of KH801 injection in patients with advanced solid tumors
主要目的:
评价 KH801 注射液治疗晚期实体瘤患者的安全性与耐受性, 确定剂量限制性毒
性(DLT) 、 最大耐受剂量(MTD) 、 II 期临床试验的推荐剂量(RP2D) 。
次要目的:
1.评价 KH801 注射液的药代动力学特征;
2. 评价 KH801 注射液的免疫原性;
3.评估 KH801 注射液治疗晚期实体瘤的初步疗效。
探索性目的:
4. 探索 KH801 注射液抗肿瘤作用的生物标志物。
[Translation] Primary purpose:
To evaluate the safety and tolerability of KH801 injection in the treatment of patients with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose (RP2D) for Phase II clinical trials.
Secondary purpose:
1. To evaluate the pharmacokinetic characteristics of KH801 injection;
2. To evaluate the immunogenicity of KH801 injection;
3. To evaluate the preliminary efficacy of KH801 injection in the treatment of advanced solid tumors.
Exploratory purpose:
4. To explore biomarkers of the anti-tumor effect of KH801 injection.