[Translation] A Phase I study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors
主要目的:●确定TGI-5注射液单药治疗在局部晚期/转移性实体瘤受试者中的MTD/OBD。●评价TGI-5注射液单药治疗在局部晚期/转移性实体瘤受试者中的安全性特征。次要目的:●评价TGI-5注射液单药治疗在局部晚期/转移性实体瘤受试者中的PK特征。●评价TGI-5注射液单药治疗在局部晚期/转移性实体瘤受试者中的初步抗肿瘤活性。●表征TGI 5注射液单药治疗在局部晚期/转移性实体瘤受试者中的免疫原性。探索性目的:●评价肿瘤组织中的CD155表达,并探索其与TGI-5注射液抗肿瘤活性和安全性之间的潜在关系。●探索剂量和PK暴露量与效应(包括有效性和/或安全性)之间的关系。
[Translation] Primary objectives: ● Determine the MTD/OBD of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. ● Evaluate the safety profile of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. Secondary objectives: ● Evaluate the PK characteristics of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. ● Evaluate the preliminary anti-tumor activity of TGI-5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. ● Characterize the immunogenicity of TGI 5 injection monotherapy in subjects with locally advanced/metastatic solid tumors. Exploratory objectives: ● Evaluate CD155 expression in tumor tissues and explore its potential relationship with the anti-tumor activity and safety of TGI-5 injection. ● Explore the relationship between dose and PK exposure and effect (including efficacy and/or safety).