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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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 on the 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] Primary objectives:
1) To evaluate the safety and tolerability of SG12473 for injection in patients with advanced malignancies;
2) To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) (Phase Ia) of SG12473 for injection for intravenous administration in patients with advanced malignancies.
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of SG12473 for injection in patients with advanced malignancies;
2) To evaluate the pharmacodynamic characteristics of SG12473 for injection in patients with advanced malignancies;
3) To evaluate the immunogenicity of SG12473 for injection in patients with advanced malignancies;
4) To preliminarily evaluate the efficacy of SG12473 for injection in patients with advanced malignancies.
Exploratory objectives:
To explore biomarkers in tumor tissue/blood that may potentially predict the efficacy of SG12473 for injection.
100 Clinical Results associated with China Gateway Biologics (Shanghai) Co., Ltd.
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