[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYH2051 alone or in combination with radiotherapy in patients with locally advanced head and neck cancer
主要目的:
Ia期:评估口服SYH2051单药在晚期实体瘤患者中的安全性和耐受性、最大耐受剂量(Maximum Tolerable Dose,MTD)(如有)或最大给药剂量(Maximum Administrated Dose,MAD);Ib/Ic期:评价SYH2051联合放疗在复发性头颈部肿瘤患者的安全性、耐受性并确定MTD(如有)和Ⅱ期推荐剂量(Recommended Phase 2 Dose,RP2D)
次要目的:
Ia期:评估SYH2051的药代动力学(PK)特征、初步抗肿瘤活性以及分析生物标志物与临床药效和安全性结果的相关性;Ib/Ic期:评价SYH2051联合放疗在复发性头颈部肿瘤患者的初步疗效和药代动力学(PK)特征
[Translation] Primary objectives:
Phase Ia: To evaluate the safety and tolerability of oral SYH2051 monotherapy in patients with advanced solid tumors, the maximum tolerated dose (MTD) (if any) or the maximum administered dose (MAD); Phase Ib/Ic: To evaluate the safety and tolerability of SYH2051 combined with radiotherapy in patients with recurrent head and neck tumors and determine the MTD (if any) and the recommended Phase 2 dose (RP2D)
Secondary objectives:
Phase Ia: To evaluate the pharmacokinetic (PK) characteristics, preliminary antitumor activity of SYH2051, and to analyze the correlation between biomarkers and clinical efficacy and safety results; Phase Ib/Ic: To evaluate the preliminary efficacy and pharmacokinetic (PK) characteristics of SYH2051 combined with radiotherapy in patients with recurrent head and neck tumors