[Translation] A multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of KF-0210 in patients with advanced solid tumors
主要目的: 评价KF-0210在晚期实体瘤患者中的安全性和耐受性; 评估KF-0210在晚期实体瘤患者的剂量限制性毒性(DLT),以确定最大耐受剂量(MTD)或最大给药剂量(MAD),初步确定II期临床推荐剂量(RP2D)。
次要目的: 评估KF-0210在晚期实体瘤患者中的药代动力学(PK)特征; 探索KF-0210在晚期实体瘤患者中的药效学特征和生物标志物; 评估KF-0210在晚期实体瘤患者中初步抗肿瘤活性。
[Translation] Primary purpose: To evaluate the safety and tolerability of KF-0210 in patients with advanced solid tumors; To evaluate the dose-limiting toxicity (DLT) of KF-0210 in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) or maximum dose (MAD), and preliminarily determine the recommended dose (RP2D) for Phase II clinical trials.
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of KF-0210 in patients with advanced solid tumors; To explore the pharmacodynamic characteristics and biomarkers of KF-0210 in patients with advanced solid tumors; To evaluate the preliminary anti-tumor activity of KF-0210 in patients with advanced solid tumors.