[Translation] An open-label phase I study evaluating the safety, tolerability, pharmacokinetics, and antitumor activity of FWD1509 MsOH in patients with advanced non-small cell lung cancer
主要目的:1.评价FWD1509 MsOH治疗晚期EGFR突变型和/或HER2突变型NSCLC患者的安全性与耐受性;2.评价晚期EGFR突变型和/或HER2突变型NSCLC患者单、多次服用FWD1509 MsOH后FWD1509 MsOH和主要代谢产物(M13)的药代动力学特征。
剂量扩展阶段主要目的:评价FWD1509 MsOH治疗晚期EGFR exon 20ins 和/或HER2突变NSCLC患者的有效性;
次要目的:确定FWD1509 MsOH在晚期EGFR突变型和/或HER2突变型NSCLC患者中的DLT、MTD、RP2D;初步抗肿瘤活性。 剂量扩展阶段次要目的:1.评价FWD1509 MsOH治疗晚期EGFR exon 20ins 和/或HER2突变NSCLC患者的安全性;2. 评价晚期NSCLC患者服用FWD1509 MsOH后FWD1509 MsOH和主要代谢产物(M13)的PK特征。3. 确定FWD1509 MsOH在晚期EGFR突变型和/或HER2突变型NSCLC患者中的RP2D。
[Translation] Primary objectives: 1. To evaluate the safety and tolerability of FWD1509 MsOH in the treatment of patients with advanced EGFR mutant and/or HER2 mutant NSCLC; 2. To evaluate the pharmacokinetic characteristics of FWD1509 MsOH and its main metabolite (M13) after single and multiple doses of FWD1509 MsOH in patients with advanced EGFR mutant and/or HER2 mutant NSCLC.
Primary objectives of the dose expansion phase: To evaluate the efficacy of FWD1509 MsOH in the treatment of patients with advanced EGFR exon 20ins and/or HER2 mutant NSCLC;
Secondary objectives: To determine the DLT, MTD, RP2D of FWD1509 MsOH in patients with advanced EGFR mutant and/or HER2 mutant NSCLC; Preliminary anti-tumor activity. Secondary objectives of the dose expansion phase: 1. To evaluate the safety of FWD1509 MsOH in the treatment of patients with advanced EGFR exon 20ins and/or HER2 mutant NSCLC; 2. To evaluate the PK characteristics of FWD1509 MsOH and the main metabolite (M13) in patients with advanced NSCLC after taking FWD1509 MsOH. 3. To determine the RP2D of FWD1509 MsOH in patients with advanced EGFR mutant and/or HER2 mutant NSCLC.