[Translation] A multicenter, open-label, dose-escalation/expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CTS2190 capsules in patients with solid tumors
剂量递增阶段:
主要目的:评估CTS2190胶囊在实体瘤患者中的安全性和耐受性,并观察CTS2190胶囊的剂量限制性毒性(DLT),确定在人体的最大耐受剂量(MTD)和/或II期研究推荐剂量(RP2D)
次要目的:评估CTS2190胶囊在实体瘤患者中的药代动力学(PK)特征;评估CTS2190胶囊在实体瘤患者中的初步抗肿瘤活性。
剂量扩展阶段:
主要目的:初步评估CTS2190胶囊在选定剂量下的抗肿瘤活性。
次要目的:评估CTS2190胶囊在选定剂量下的安全性;评估CTS2190胶囊在选定剂量下的其他抗肿瘤活性;评估CTS2190胶囊在选定剂量下实体瘤患者中的PD特征。
[Translation] Dose escalation phase:
Primary purpose: To evaluate the safety and tolerability of CTS2190 capsules in patients with solid tumors, and to observe the dose-limiting toxicity (DLT) of CTS2190 capsules, and to determine the maximum tolerated dose (MTD) and/or recommended dose (RP2D) for Phase II studies in humans
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of CTS2190 capsules in patients with solid tumors; to evaluate the preliminary anti-tumor activity of CTS2190 capsules in patients with solid tumors.
Dose expansion phase:
Primary purpose: To preliminarily evaluate the anti-tumor activity of CTS2190 capsules at the selected dose.
Secondary purpose: To evaluate the safety of CTS2190 capsules at the selected dose; to evaluate other anti-tumor activities of CTS2190 capsules at the selected dose; to evaluate the PD characteristics of CTS2190 capsules in patients with solid tumors at the selected dose.