[Translation] A dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and biological effects of recombinant human IL-21 oncolytic poxvirus injection (hV01) in the treatment of advanced malignant solid tumors that are ineffective or have failed standard treatment.
主要目的:
1. 评价hV01治疗末线晚期恶性实体瘤的安全性和耐受性;
2. 探索hV01的最大耐受剂量(MTD),确定Ⅱ期临床试验的推荐剂量(RP2D)。
次要目的:
1. 初步评价hV01瘤内注射给药的药代动力学(PK)特征及病毒排出情况;
2. 初步评价hV01瘤内注射给药治疗末线晚期恶性实体瘤的有效性(根据RECIST v1.1和iRECIST标准)。
[Translation] Primary objectives:
1. To evaluate the safety and tolerability of hV01 in the treatment of terminal advanced malignant solid tumors;
2. To explore the maximum tolerated dose (MTD) of hV01 and determine the recommended dose (RP2D) for Phase II clinical trials.
Secondary objectives:
1. To preliminarily evaluate the pharmacokinetic (PK) characteristics and viral excretion of hV01 after intratumoral injection;
2. To preliminarily evaluate the effectiveness of hV01 intratumoral injection in the treatment of terminal advanced malignant solid tumors (according to RECIST v1.1 and iRECIST standards).