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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
瘤内注射CAN1012注射液在晚期实体瘤患者中的安全性、耐受性及初步有效性的Ⅰ期临床试验
[Translation] Phase I clinical trial of the safety, tolerability and preliminary efficacy of intratumoral CAN1012 injection in patients with advanced solid tumors
主要目的:
1) 评估CAN1012注射液在晚期实体瘤患者中的安全性和耐受性;
2) 确定最大耐受剂量(MTD)和/或Ⅱ期推荐剂量(RP2D)。
次要目的:
1) 评估CAN1012注射液在晚期实体瘤患者中的药代动力学(PK)特征;
2) 评估CAN1012注射液在晚期实体瘤患者中的初步有效性。
探索性目的:
1) 评估CAN1012注射液在晚期实体瘤患者中的药效动力学(PD)特征;
2) 探索生物标志物(包括CD3、CD8、PD-L1、BDCA2)与CAN1012注射液有效性的相关性。
[Translation] Primary objectives:
1) To evaluate the safety and tolerability of CAN1012 injection in patients with advanced solid tumors;
2) To determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics of CAN1012 injection in patients with advanced solid tumors;
2) To evaluate the preliminary efficacy of CAN1012 injection in patients with advanced solid tumors.
Exploratory objectives:
1) To evaluate the pharmacodynamic (PD) characteristics of CAN1012 injection in patients with advanced solid tumors;
2) To explore the correlation between biomarkers (including CD3, CD8, PD-L1, BDCA2) and the efficacy of CAN1012 injection.
100 Clinical Results associated with IriSys, Inc.
0 Patents (Medical) associated with IriSys, Inc.
100 Deals associated with IriSys, Inc.
100 Translational Medicine associated with IriSys, Inc.