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Clinical Trials associated with SG-2918A Phase I Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of SG2918 in Subjects With Advanced Malignant Tumors
This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 in subjects with Advanced Malignant Tumors who are refractory or resistant to standard therapy, or without available standard or curative therapy.
Start Date26 Dec 2023 |
Sponsor / Collaborator- |
评估注射用SG2918在晚期恶性肿瘤患者中安全性、耐受性和初步有效性的I期临床研究
[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.
100 Clinical Results associated with SG-2918
100 Translational Medicine associated with SG-2918
100 Patents (Medical) associated with SG-2918
100 Deals associated with SG-2918