[Translation] A phase I clinical study of the safety, tolerability and preliminary anti-tumor activity of WTS-004 in patients with EGFR mutation-positive advanced non-small cell lung cancer with central nervous system metastases.
主要目的
剂量递增阶段: 1.评估 WTS-004 在经过充分 EGFR-TKI 治疗后疾病进展、且至少经过含铂化疗治疗后疾病进展或对含铂治疗不耐受的 EGFR
突变阳性晚期非小细胞肺癌患者中的安全性、耐受性。
2.确定最大耐受剂量(MTD)。
剂量扩展阶段:
1.评估 WTS-004 在经 EGFR-TKI 治疗后以中枢神经系统(CNS)转移为疾病进展首要原因的 EGFR 突变
阳性晚期非小细胞肺癌患者中的安全性。 2.确定 II 期推荐剂量(RP2D)。
次要目的
1.评价 WTS-004 片在晚期非小细胞肺癌患者体内的药代动力学特征;
2.评价 WTS-004 片在晚期非小细胞肺癌患者中的初步抗肿瘤活性。
探索性目的
剂量扩展阶段:探索 WTS-004 对晚期非小细胞肺癌患者颅外病灶的疗效。
[Translation] Main purpose
Dose escalation phase: 1. Evaluate the safety and tolerability of WTS-004 in patients with EGFR mutation-positive advanced non-small cell lung cancer who have progressed after adequate EGFR-TKI treatment and have progressed after at least platinum-containing chemotherapy or are intolerant to platinum-containing treatment.
2. Determine the maximum tolerated dose (MTD).
Dose expansion phase:
1. Evaluate the safety of WTS-004 in patients with EGFR mutation-positive advanced non-small cell lung cancer with central nervous system (CNS) metastasis as the primary cause of disease progression after EGFR-TKI treatment. 2. Determine the recommended dose for Phase II (RP2D).
Secondary purpose
1. Evaluate the pharmacokinetic characteristics of WTS-004 tablets in patients with advanced non-small cell lung cancer;
2. Evaluate the preliminary anti-tumor activity of WTS-004 tablets in patients with advanced non-small cell lung cancer.
Exploratory purpose
Dose expansion phase: Explore the efficacy of WTS-004 on extracranial lesions in patients with advanced non-small cell lung cancer.