AL8326片治疗至少接受二线治疗方案后疾病进展或复发的小细胞肺癌患者的III期临床研
究
[Translation] Phase III clinical study of AL8326 tablets in the treatment of patients with small cell lung cancer who have had disease progression or recurrence after at least two lines of treatment
主要目的
评价AL8326片单药治疗二线及以上系统性方案治疗后复发或进展的小细胞肺癌患者的总生存期(OS)疗效。
次要目的
评价AL8326片单药在二线及以上系统性方案治疗后复发或进展的小细胞肺癌患者中的无进展生存期(PFS)和其他有效性指标.
[Translation] Primary objective
To evaluate the overall survival (OS) efficacy of AL8326 tablets as a single agent in patients with small cell lung cancer who have relapsed or progressed after second-line or higher systemic treatment.
Secondary objective
To evaluate the progression-free survival (PFS) and other efficacy indicators of AL8326 tablets as a single agent in patients with small cell lung cancer who have relapsed or progressed after second-line or higher systemic treatment.
一项评估高脂饮食对中国健康成年受试者口服AL8326片后药代动力学影响的Ib 期临床试验
[Translation] A Phase Ib clinical trial evaluating the effect of a high-fat diet on the pharmacokinetics of AL8326 tablets in healthy Chinese adult subjects
主要研究目的:高脂饮食对中国健康成年受试者口服 AL8326 片后 AL8326 的药代动力学影响。
次要研究目的:健康受试者单剂量口服AL8326片的安全性和耐受性。
[Translation] Primary study objective: Effect of a high-fat diet on the pharmacokinetics of AL8326 after oral administration of AL8326 tablets in healthy Chinese adult subjects.
Secondary study objective: Safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects.
一项AL8326 片联合特瑞普利单抗治疗晚期复发或转移性实体瘤I/IIa期临床试验
[Translation] A Phase I/IIa clinical trial of AL8326 tablets combined with toripalimab in the treatment of advanced recurrent or metastatic solid tumors
主要目的:评估 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤的安全性及耐受性,观 察 DLT 的发生,确定 MTD 及 RP2D。
次要目的:初步获得 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤受试者的药代动力 学参数(仅第一部分)。 初步评价 AL8326 片联合特瑞普利单抗(Toripalimab)治疗晚期实体瘤的有效性
[Translation] Primary objective: To evaluate the safety and tolerability of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors, observe the occurrence of DLT, and determine the MTD and RP2D.
Secondary objective: To preliminarily obtain the pharmacokinetic parameters of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors (only the first part). Preliminary evaluation of the effectiveness of AL8326 tablets combined with Toripalimab in the treatment of advanced solid tumors
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