[Translation] A dose-escalation, open-label phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and biological effects of VG2025 in patients with advanced malignant solid tumors
主要目的:
1)评价在经标准治疗失败,现阶段无有效治疗手段的晚期恶性实体瘤患者中肿瘤内注射VG2025的安全性和耐受性。
2)探索VG2025给药的最大耐受剂量(MTD),确定II期临床试验推荐剂量(RP2D)。
次要目的:
1)评价VG2025肿瘤内注射给药的药代动力学(PK)特征及病毒排出情况。
2)通过客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)和总生存期(OS),初步评价VG2025单药治疗的抗肿瘤疗效。
3)监测VG2025相关的药效动力学特征和免疫原性。
4)评价外周血癌胚抗原(CEA)水平与安全性和有效性的可能相关性。
[Translation] main purpose:
1) To evaluate the safety and tolerability of intratumoral injection of VG2025 in patients with advanced malignant solid tumors who have failed standard therapy and have no effective treatment at this stage.
2) Explore the maximum tolerated dose (MTD) of VG2025 administration and determine the recommended dose (RP2D) for phase II clinical trials.
Secondary purpose:
1) To evaluate the pharmacokinetic (PK) characteristics and viral shedding of VG2025 administered by intratumoral injection.
2) The anti-tumor efficacy of VG2025 monotherapy was preliminarily evaluated by objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).
3) Monitor VG2025-related pharmacodynamic characteristics and immunogenicity.
4) To evaluate the possible correlation of peripheral blood carcinoembryonic antigen (CEA) levels with safety and efficacy.