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Drug Highest PhasePhase 1 |
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/ Not yet recruitingPhase 1 评价E10K-1A在晚期恶性实体肿瘤中安全性与有效性的临床研究
[Translation] Clinical studies evaluating the safety and efficacy of E10K-1A in advanced malignant solid tumors.
主要目的:
1.评价E10K-1A单次和多次瘤内注射在晚期恶性实体肿瘤患者中的安全性和耐受性。
2. 探索E10K-1A单次和多次瘤内注射的剂量限制性毒性(DLT)和最大耐受剂量(MTD)。
次要目的:
1.评价E10K-1A单次和多次瘤内注射在晚期恶性实体肿瘤患者中的初步疗效。
2.评价E10K-1A单次和多次瘤内注射在晚期恶性实体肿瘤中的药代动力学和药效学特征。
3.评价E10K-1A单次和多次瘤内注射在晚期恶性实体肿瘤患者中的免疫原性特征。
探索目的:
1.评价单次及多次瘤内注射E10K-1A在晚期恶性实体瘤患者中的病毒脱落情况。
2. 评价肿瘤p53、pRb/p16、CD46表达情况与E10K-1A有效性的相关性
[Translation] Primary Objectives:
1. To evaluate the safety and tolerability of single and multiple intratumoral injections of E10K-1A in patients with advanced malignant solid tumors.
2. To explore the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of single and multiple intratumoral injections of E10K-1A.
Secondary Objectives:
1. To evaluate the preliminary efficacy of single and multiple intratumoral injections of E10K-1A in patients with advanced malignant solid tumors.
2. To evaluate the pharmacokinetic and pharmacodynamic characteristics of single and multiple intratumoral injections of E10K-1A in advanced malignant solid tumors.
3. To evaluate the immunogenicity of single and multiple intratumoral injections of E10K-1A in patients with advanced malignant solid tumors.
Exploratory Objectives:
1. To evaluate viral shedding after single and multiple intratumoral injections of E10K-1A in patients with advanced malignant solid tumors.
2. To evaluate the correlation between tumor p53, pRb/p16, and CD46 expression and the efficacy of E10K-1A.
100 Clinical Results associated with Chimin Boao International Hospital Co., Ltd.
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100 Deals associated with Chimin Boao International Hospital Co., Ltd.
100 Translational Medicine associated with Chimin Boao International Hospital Co., Ltd.