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MechanismPI3K family inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价PI3K抑制剂TL117胶囊单药以及联合紫杉醇在复发/转移性头颈部鳞癌患者中的安全性、耐受性、药代动力学特征及初步疗效的I/II期临床试验
[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.
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