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Clinical Trials associated with VT1093VT1093瘤内注射治疗成人复发或转移性恶性实体瘤的开放、剂量递增的Ⅰ期临床试验
[Translation] An open-label, dose-escalating phase I clinical trial of intratumoral injection of VT1093 for the treatment of recurrent or metastatic malignant solid tumors in adults
主要目的:
评价VT1093瘤内单次给药及多次给药在复发或转移性实体瘤受试者中的安全性及耐受性,探索人体的最大耐受剂量(MTD)及剂量限制性毒性(DLT),为本品的后续拓展试验及Ⅱ期临床研究推荐安全剂量范围。
次要目的:
评估VT1093瘤内单次给药及多次给药在人体内的生物分布及生物效应。
初步评价VT1093治疗复发或转移性实体瘤的客观有效率(ORR),疾病控制率(DCR)。
[Translation] Main purpose:
Evaluate the safety and tolerability of VT1093 in subjects with recurrent or metastatic solid tumors after single and multiple intratumoral administration, explore the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in humans, and recommend a safe dose range for subsequent extended trials and Phase II clinical studies of this product.
Secondary purpose:
Evaluate the biodistribution and biological effects of VT1093 in humans after single and multiple intratumoral administration.
Preliminary evaluation of the objective response rate (ORR) and disease control rate (DCR) of VT1093 in the treatment of recurrent or metastatic solid tumors.
100 Clinical Results associated with VT1093
100 Translational Medicine associated with VT1093
100 Patents (Medical) associated with VT1093
100 Deals associated with VT1093