[Translation] Phase Ib/IIa clinical trial to evaluate the safety, tolerability and preliminary efficacy of intratumoral CAN1012 injection combined with toripalimab in patients with advanced solid tumors
主要目的:
1) 评估CAN1012注射液联合特瑞普利单抗在晚期实体瘤参与者中的安全性和耐受性;
2) 确定CAN1012注射液联合特瑞普利单抗的最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。
次要目的:
1) 评估CAN1012注射液联合特瑞普利单抗在晚期实体瘤参与者中的初步有效性;
2) 评估CAN1012注射液联合特瑞普利单抗在晚期实体瘤参与者中的药效动力学(PD)特征。
[Translation] Primary objectives:
1) To evaluate the safety and tolerability of CAN1012 injection combined with toripalimab in participants with advanced solid tumors;
2) To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CAN1012 injection combined with toripalimab.
Secondary objectives:
1) To evaluate the preliminary efficacy of CAN1012 injection combined with toripalimab in participants with advanced solid tumors;
2) To evaluate the pharmacodynamic (PD) characteristics of CAN1012 injection combined with toripalimab in participants with advanced solid tumors.