[Translation] A Phase I clinical study on the safety, tolerability and preliminary efficacy of SG1827 for injection in subjects with advanced malignant solid tumors
Ia期研究目的:主要目的:1)安全性和耐受性;2)探索MTD或MAD。次要目的:1)评估SG1827在晚期恶性实体瘤受试者中的PK、PD特征;2)评估SG1827的免疫原性;3)评价SG1827单药治疗的初步抗肿瘤疗效。
Ib期研究目的: 主要目的:1)安全性和耐受性;2)确定SG1827在晚期恶性实体瘤受试者中的RP2D;3)评价SG1827在晚期恶性实体瘤受试者中的抗肿瘤活性。
次要目的:1)评价SG1827在晚期恶性实体瘤受试者中的其他疗效;2)评估PK、PD特征;3)评估SG1827的免疫原性。
探索性目的:探索肿瘤组织/血液中潜在预测SG1827疗效的生物标志物。
[Translation] Phase Ia study objectives: Primary objectives: 1) Safety and tolerability; 2) Explore MTD or MAD. Secondary objectives: 1) Evaluate the PK and PD characteristics of SG1827 in subjects with advanced malignant solid tumors; 2) Evaluate the immunogenicity of SG1827; 3) Evaluate the preliminary anti-tumor efficacy of SG1827 monotherapy.
Phase Ib study objectives: Primary objectives: 1) Safety and tolerability; 2) Determine the RP2D of SG1827 in subjects with advanced malignant solid tumors; 3) Evaluate the anti-tumor activity of SG1827 in subjects with advanced malignant solid tumors.
Secondary objectives: 1) Evaluate other efficacy of SG1827 in subjects with advanced malignant solid tumors; 2) Evaluate PK and PD characteristics; 3) Evaluate the immunogenicity of SG1827.
Exploratory objectives: Explore biomarkers in tumor tissue/blood that potentially predict the efficacy of SG1827.