[Translation] A multicenter, open-label phase I/II clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and antitumor activity of oral HX1408 tablets in Chinese patients with recurrent or progressive glioblastoma, using single and multiple doses.
主要目的:I期剂量递增研究:1.评价HX1408片治疗复发或进展性胶质母细胞瘤患者的安全性和耐受性,确定最大耐受剂量和/或II期推荐剂量。II期剂量扩展研究:1.评价HX1408在复发或进展性胶质母细胞瘤患者中基于盲态的独立评审委员会评估的客观缓解率和无进展生存期。次要目的:I期剂量递增研究:1.评价HX1408在复发或进展性胶质母细胞瘤患者中的药代动力学;2.评价HX1408在复发或进展性胶质母细胞瘤患者中研究者评估的客观缓解率、无进展生存期、疾病控制率、缓解持续时间;3.评价HX1408在复发或进展性胶质母细胞瘤患者中的总生存期;II期剂量扩展研究:1.评价HX1408的安全性;2.评价HX1408在复发或进展性胶质母细胞瘤患者中研究者评估的客观缓解率和无进展生存期;3.评价HX1408在复发或进展性胶质母细胞瘤患者中BIRC和研究者评估的6个月无进展生存率、疾病控制率、缓解持续时间;4.评价HX1408在复发或进展性胶质母细胞瘤患者中的总生存期、12个月生存率;评价HX1408在复发或进展性胶质母细胞瘤患者中的药代动力学特征。
[Translation] Primary Objectives: Phase I Dose Escalation Study: 1. To evaluate the safety and tolerability of HX1408 tablets in patients with relapsed or progressive glioblastoma, and to determine the maximum tolerated dose and/or the recommended dose for Phase II. Phase II Dose Extension Study: 1. To evaluate the objective response rate and progression-free survival of HX1408 in patients with relapsed or progressive glioblastoma, assessed by a blinded independent review committee. Secondary Objectives: Phase I Dose Escalation Study: 1. To evaluate the pharmacokinetics of HX1408 in patients with relapsed or progressive glioblastoma; 2. To evaluate the investigator-assessed objective response rate, progression-free survival, disease control rate, and duration of response of HX1408 in patients with relapsed or progressive glioblastoma; 3. To evaluate the overall survival of HX1408 in patients with relapsed or progressive glioblastoma; Phase II Dose Extension Study: 1. To evaluate the safety of HX1408; 2. To evaluate the efficacy of HX1408 in patients with relapsed or progressive glioblastoma. 08. Investigator-assessed objective response rate and progression-free survival in patients with recurrent or progressive glioblastoma; 3. Evaluation of 6-month progression-free survival, disease control rate, and duration of response of HX1408 in patients with recurrent or progressive glioblastoma, as assessed by BIRC and investigators; 4. Evaluation of overall survival and 12-month survival of HX1408 in patients with recurrent or progressive glioblastoma; Evaluation of pharmacokinetic characteristics of HX1408 in patients with recurrent or progressive glioblastoma.