[Translation] A phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of PI3K inhibitor TL117 capsule alone and in combination with paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma
评价TL117胶囊联合紫杉醇用于经一线铂类药物治疗失败的复发/转移性头颈部鳞癌患者的安全性和耐受性,探索最大耐受剂量(MTD),并确定II期推荐剂量(RP2D);评价抗肿瘤疗效;评价药代动力学特征。
[Translation] To evaluate the safety and tolerability of TL117 capsule combined with paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma who have failed first-line platinum-based treatment, explore the maximum tolerated dose (MTD), and determine the recommended phase II dose (RP2D); evaluate the anti-tumor efficacy; and evaluate the pharmacokinetic characteristics.