[Translation] A Phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of TGI-6 monotherapy for injection in subjects with locally advanced or metastatic solid tumors
Ia期:主要目的:1、确定注射用TGI-6 在局部晚期或转移性实体瘤受试者中的MTD/RP2D。2、评价注射用TGI-6在局部晚期或转移性实体瘤受试者中的安全性特征。
次要目的:1、评价注射用TGI-6 在局部晚期或转移性实体瘤受试者中的PK特征。2、评价注射用TGI-6 在局部晚期或转移性实体瘤受试者中的初步抗肿瘤活性。3、表征注射用TGI-6在局部晚期或转移性实体瘤受试者中的免疫原性。
Ib期:主要目的:评价注射用TGI-6在局部晚期或转移性 CRC 受试者或经确认B7-H6阳性的局部晚期或转移性实体瘤受试者中的抗肿瘤活性。
次要目的:评价注射用TGI-6在局部晚期或转移性CRC 和经确认B7-H6阳性的局部晚期或转移性实体瘤受试者中的其他抗肿瘤活性终点、
总体安全性特征、PK特征,以及表征注射用TGI-6在局部晚期或转移性CRC 受试者或经确认B7-H6阳性的局部晚期或转移性实体瘤受试者中的免疫原性。
[Translation] Phase Ia: Primary objectives: 1. Determine the MTD/RP2D of TGI-6 for injection in subjects with locally advanced or metastatic solid tumors. 2. Evaluate the safety profile of TGI-6 for injection in subjects with locally advanced or metastatic solid tumors.
Secondary objectives: 1. Evaluate the PK characteristics of TGI-6 for injection in subjects with locally advanced or metastatic solid tumors. 2. Evaluate the preliminary anti-tumor activity of TGI-6 for injection in subjects with locally advanced or metastatic solid tumors. 3. Characterize the immunogenicity of TGI-6 for injection in subjects with locally advanced or metastatic solid tumors.
Phase Ib: Primary objectives: Evaluate the anti-tumor activity of TGI-6 for injection in subjects with locally advanced or metastatic CRC or subjects with locally advanced or metastatic solid tumors confirmed to be B7-H6 positive.
Secondary objectives: To evaluate other antitumor activity endpoints, overall safety profile, PK profile of TGI-6 for injection in subjects with locally advanced or metastatic CRC and locally advanced or metastatic solid tumors confirmed to be B7-H6 positive, and to characterize the immunogenicity of TGI-6 for injection in subjects with locally advanced or metastatic CRC or locally advanced or metastatic solid tumors confirmed to be B7-H6 positive.