[Translation] Phase I clinical study of SG404 for injection in patients with advanced malignant tumors
主要目的:
1) 评价注射用SG404在晚期恶性肿瘤患者中的安全性和耐受性。
2) 确定注射用SG404静脉给药在晚期恶性肿瘤患者中的剂量限制性毒性(DLT)和最大耐受剂量(MTD),为II期临床试验给药方案和给药剂量提供依据。
次要目的:
1) 评价注射用SG404在晚期恶性肿瘤患者中的药代动力学特征。
2) 评价注射用SG404在晚期恶性肿瘤患者中的药效动力学特征。
3) 评价注射用SG404在晚期恶性肿瘤患者中的免疫原性。
4) 初步评价注射用SG404在晚期恶性肿瘤患者中的疗效。
探索性目的:
探索肿瘤组织中潜在预测注射用SG404疗效的生物标志物。
[Translation] main purpose:
1) To evaluate the safety and tolerability of SG404 for injection in patients with advanced malignant tumors.
2) To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of intravenous administration of SG404 for injection in patients with advanced malignant tumors, and to provide the basis for the dosing schedule and dosage of phase II clinical trials.
Secondary purpose:
1) To evaluate the pharmacokinetics of SG404 for injection in patients with advanced malignant tumors.
2) To evaluate the pharmacodynamics of SG404 for injection in patients with advanced malignant tumors.
3) To evaluate the immunogenicity of SG404 for injection in patients with advanced malignant tumors.
4) Preliminary evaluation of the efficacy of SG404 for injection in patients with advanced malignant tumors.
Exploratory Purpose:
To explore potential biomarkers in tumor tissue to predict the efficacy of SG404 for injection.