APL-102胶囊治疗晚期实体瘤患者的安全性,耐受性及药代动力学的I期临床研究
[Translation] Phase I clinical study of safety, tolerability and pharmacokinetics of APL-102 capsules in the treatment of patients with advanced solid tumors
主要目的:1、 评价APL-102胶囊的单次给药及多次给药的安全性及耐受性;2、确定最大耐受剂量(MTD)及推荐的Ⅱ期研究剂量(RP2D)。次要目的: 1、研究APL-102在晚期实体瘤患者中的人体药代动力学(PK)特征;2、在晚期实体瘤患者中评价APL-102胶囊给药的初步抗肿瘤活性。探索性目的:评估受试者血液中的 VEGF-A,M-CSF,sVEGFR2及 CD14dim/CD16+ 单核细胞水平在接受 APL-102治疗前后的变化,探索生物标治疗前后的变化,探索生物标志物与APL-102疗效的潜在相关性。 评估肿瘤组织中 CSF1R,CD68,CD163,CD16, DDR1,CD3,CD4,CD8等药效学靶点和潜在的生物标志与APL-102疗效的潜在联系。
[Translation] Main purposes: 1. To evaluate the safety and tolerability of single and multiple administration of APL-102 capsules; 2. To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Secondary objectives: 1. To study the human pharmacokinetics (PK) characteristics of APL-102 in patients with advanced solid tumors; 2. To evaluate the preliminary antitumor activity of APL-102 capsules in patients with advanced solid tumors. Exploratory purpose: To evaluate the changes of VEGF-A, M-CSF, sVEGFR2 and CD14dim/CD16+ monocytes in the blood of subjects before and after APL-102 treatment, to explore the changes of biomarkers before and after treatment, to explore biomarkers Potential correlation with efficacy of APL-102. Pharmacodynamic targets and potential biomarkers such as CSF1R, CD68, CD163, CD16, DDR1, CD3, CD4, CD8 in tumor tissues were evaluated for their potential association with the efficacy of APL-102.
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