[Translation] A Phase I clinical study to evaluate the safety, tolerability and preliminary efficacy of SG2918 for injection in patients with advanced malignant 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SG2918在晚期恶性肿瘤患者中的PK、PD特征;
2)评估SG2918的免疫原性;
3)评价SG2918在晚期恶性肿瘤患者治疗的初步抗肿瘤疗效
Ib期研究目的:
主要目的:
1)进一步评估SG2918在晚期恶性肿瘤患者中的安全性和耐受性;
2)确定SG2918在晚期恶性肿瘤患者中的RP2D;
3)进一步评价SG2918单药治疗的初步抗肿瘤疗效。
次要目的:
1)进一步评估SG2918在晚期恶性肿瘤患者中的PK、PD特征;
2)进一步评估SG2918的免疫原性;
探索性目的:探索肿瘤组织中的免疫细胞亚群分析。
[Translation] Phase Ia study objectives:
Main objectives: 1) Safety and tolerability;
2) Explore MTD or MAD.
Secondary objectives:
1) Evaluate the PK and PD characteristics of SG2918 in patients with advanced malignant tumors;
2) Evaluate the immunogenicity of SG2918;
3) Evaluate the preliminary anti-tumor efficacy of SG2918 in patients with advanced malignant tumors
Purpose of Phase Ib study:
Main objectives:
1) Further evaluate the safety and tolerability of SG2918 in patients with advanced malignant tumors;
2) Determine the RP2D of SG2918 in patients with advanced malignant tumors;
3) Further evaluate the preliminary anti-tumor efficacy of SG2918 monotherapy.
Secondary objectives:
1) Further evaluate the PK and PD characteristics of SG2918 in patients with advanced malignant tumors;
2) Further evaluate the immunogenicity of SG2918;
Exploratory objectives: Explore the analysis of immune cell subsets in tumor tissues.