[Translation] An open, single-arm, multicenter phase I clinical study on the tolerability, safety, immunodynamic characteristics and preliminary clinical efficacy of IPM001 in the treatment of advanced primary hepatocellular carcinoma
主要目的
1)评价IPM001注射液治疗进展期原发性肝细胞癌患者的安全性和耐受性;
2)评估IPM001注射液的药代动力学(免疫动力学)特征;
3)确定IPM001注射液II期临床试验推荐剂量(RP2D);
次要目的
1)评估IPM001注射液治疗进展期原发性肝细胞癌的初步临床有效性。
探索性目的
2)探索IPM001注射液诱导的免疫应答与临床疗效的相关性。
[Translation] Main purpose
1) Evaluate the safety and tolerability of IPM001 injection in the treatment of patients with advanced primary hepatocellular carcinoma;
2) Evaluate the pharmacokinetic (immunokinetic) characteristics of IPM001 injection;
3) Determine the recommended dose (RP2D) for the Phase II clinical trial of IPM001 injection;
Secondary purpose
1) Evaluate the preliminary clinical efficacy of IPM001 injection in the treatment of advanced primary hepatocellular carcinoma.
Exploratory purpose
2) Explore the correlation between the immune response induced by IPM001 injection and clinical efficacy.