注射用SG12473 在晚期恶性肿瘤患者的安全性、耐受性和初步有效性的Ia/Ib 期临床研究
[Translation] Phase Ia/Ib clinical study of safety, tolerability and preliminary efficacy of SG12473 for injection in patients with advanced malignant tumors
主要目的:
1) 评估注射用SG12473 在晚期恶性肿瘤患者中的安全性和耐受性;
2) 确定注射用SG12473 静脉给药在晚期恶性肿瘤患者中的最大耐受剂量(MTD)和/或II 期推荐剂量(RP2D)(Ia 期)。
次要目的:
1) 评估注射用SG12473 在晚期恶性肿瘤患者中的药代动力学特征;
2) 评估注射用SG12473 在晚期恶性肿瘤患者中的药效动力学特征;
3) 评估注射用SG12473 在晚期恶性肿瘤患者中的免疫原性;
4) 初步评价注射用SG12473 在晚期恶性肿瘤患者中的疗效。
探索性目的:
探索肿瘤组织/血液中潜在预测注射用SG12473 疗效的生物标志物。
[Translation] main purpose:
1) To evaluate the safety and tolerability of SG12473 for injection in patients with advanced malignant tumors;
2) To determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) of SG12473 for injection administered intravenously in patients with advanced malignancies (Phase Ia).
Secondary purpose:
1) To evaluate the pharmacokinetics of SG12473 for injection in patients with advanced malignant tumors;
2) To evaluate the pharmacodynamics of SG12473 for injection in patients with advanced malignant tumors;
3) To evaluate the immunogenicity of SG12473 for injection in patients with advanced malignant tumors;
4) Preliminary evaluation of the efficacy of SG12473 for injection in patients with advanced malignant tumors.
Exploratory Purpose:
To explore potential biomarkers in tumor tissue/blood to predict the efficacy of SG12473 for injection.
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