[Translation] A phase I clinical study to evaluate the safety, tolerability, biodistribution characteristics and biological effects of SynOV1.1 adenovirus injection as a single agent in patients with locally advanced or metastatic solid tumors
主要目的:
评价 SynOV1.1 腺病毒注射液(简称 SynOV1.1)在局部晚期或转移性实体瘤患者中的安全性和耐受性。
次要目的:
1. 考察不同剂量 SynOV1.1 在局部晚期或转移性实体瘤患者中的生物学分布和生物效应。
2. 评价不同剂量 SynOV1.1 在局部晚期或转移性实体瘤患者中的免疫原性。
3. 初步评价不同剂量 SynOV1.1 在局部晚期或转移性实体瘤患者中的疗效。
探索性目的:
1. 探索给予 SynOV1.1 治疗局部晚期或转移性实体患者后的抗肿瘤免疫反应及其与安全性、耐受性和疗效的相关性。
2. 探索基线血浆外泌体的水平预测 SynOV1.1 治疗局部晚期或转移性实体瘤患者的抗肿瘤疗效。
[Translation] main purpose:
To evaluate the safety and tolerability of SynOV1.1 adenovirus injection (SynOV1.1 for short) in patients with locally advanced or metastatic solid tumors.
Secondary purpose:
1. To investigate the biological distribution and biological effects of different doses of SynOV1.1 in patients with locally advanced or metastatic solid tumors.
2. To evaluate the immunogenicity of different doses of SynOV1.1 in patients with locally advanced or metastatic solid tumors.
3. Preliminary evaluation of the efficacy of different doses of SynOV1.1 in patients with locally advanced or metastatic solid tumors.
Exploratory Purpose:
1. To explore the anti-tumor immune response after administration of SynOV1.1 in locally advanced or metastatic solid patients and its correlation with safety, tolerability and efficacy.
2. To explore baseline plasma exosome levels to predict the antitumor efficacy of SynOV1.1 in patients with locally advanced or metastatic solid tumors.