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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
注射用anti-PD-L1治疗晚期实体瘤患者的耐受性及药代动力学的Ia期临床试验
[Translation] Phase Ia clinical trial of tolerability and pharmacokinetics of injectable anti-PD-L1 in patients with advanced solid tumors
主要目的:评价注射用anti-PD-L1的安全性和耐受性;探索注射用anti-PD-L1的最大耐受剂量,确定2期推荐剂量。 次要目的:观察anti-PD-L1的药代动力学特征;通过测试抗药物抗体的产生来评估anti-PD-L1的免疫原性;初步评价anti-PD-L1的抗肿瘤疗效。 探索性目的:探索anti-PD-L1的药效学特征。
[Translation] Primary objectives: To evaluate the safety and tolerability of anti-PD-L1 for injection; to explore the maximum tolerated dose of anti-PD-L1 for injection and determine the recommended dose for Phase 2. Secondary objectives: To observe the pharmacokinetic characteristics of anti-PD-L1; to evaluate the immunogenicity of anti-PD-L1 by testing the production of anti-drug antibodies; and to preliminarily evaluate the anti-tumor efficacy of anti-PD-L1. Exploratory objectives: To explore the pharmacodynamic characteristics of anti-PD-L1.
100 Clinical Results associated with Jiangsu Huaiyu Pharmaceutical Co., Ltd.
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100 Deals associated with Jiangsu Huaiyu Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangsu Huaiyu Pharmaceutical Co., Ltd.