[Translation] An open-label, multicenter, Phase I/II study evaluating the safety, tolerability, pharmacokinetics, and efficacy of ALK-N001 for injection in patients with advanced solid tumors
Ia期评价注射用ALK-N001在晚期实体瘤患者中的安全性和耐受性;确定注射用ALK-N001推荐II期剂量(RP2D) 和/或最大耐受剂量(MTD);评价注射用ALK-N001在不同给药方案下人体药代动力学特征,获取初步药代动力学参数(PK);初步评价注射用ALK-N001在晚期实体瘤患者中的有效性;注射用ALK-N001在血液中的代谢产物鉴定(如适用);Ib/II期评价注射用ALK-N001在晚期实体瘤如食管鳞癌、小细胞肺癌和胃/食管胃交界处腺癌等患者中的有效性;进一步评价注射用ALK-N001在晚期实体瘤如食管鳞癌、小细胞肺癌和胃/食管胃交界处腺癌等患者中的安全性;进一步评价注射用ALK-N001在食管鳞癌、小细胞肺癌和胃/食管胃交界处腺癌等患者中的PK参数;注射用ALK-N001在血液中的代谢产物鉴定(如适用)
[Translation] Phase Ia study to evaluate the safety and tolerability of ALK-N001 for injection in patients with advanced solid tumors; to determine the recommended Phase II dose (RP2D) of ALK-N001 for injection and/or maximum tolerated dose (MTD); evaluate the human pharmacokinetic characteristics of ALK-N001 for injection under different dosing regimens and obtain preliminary pharmacokinetic parameters (PK); preliminarily evaluate the effectiveness of ALK-N001 for injection in patients with advanced solid tumors; identify the metabolites of ALK-N001 for injection in the blood (if applicable); Phase Ib/II evaluation of the effectiveness of ALK-N001 for injection in patients with advanced solid tumors such as esophageal squamous cell carcinoma, small cell lung cancer, and gastric/esophagogastric junction adenocarcinoma; further evaluate the safety of ALK-N001 for injection in patients with advanced solid tumors such as esophageal squamous cell carcinoma, small cell lung cancer, and gastric/esophagogastric junction adenocarcinoma; further evaluate the PK parameters of ALK-N001 for injection in patients with esophageal squamous cell carcinoma, small cell lung cancer, and gastric/esophagogastric junction adenocarcinoma; identify the metabolites of ALK-N001 for injection in the blood (if applicable)