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Clinical Trials associated with EX-101一项开放性、剂量递增和剂量扩展评估EX101注射液治疗HER2阳性晚期实体瘤患者的I期临床研究
[Translation] An open-label, dose-escalation and dose-expansion phase I clinical study evaluating EX101 injection in patients with HER2-positive advanced solid tumors
剂量递增阶段:一、主要研究目的:1)评价EX101注射液在HER2阳性晚期实体瘤患者中的安全性、耐受性;2)探索剂量限制性毒性 (DLT),确定最大耐受剂量 (MTD)或II期临床试验推荐剂量(RP2D)。二、次要研究目的:1)评价EX101注射液在HER2阳性晚期实体瘤患者中的药代动力学特征;2)评价EX101注射液在HER2阳性晚期实体瘤患者中的初步有效性;3)评价EX101注射液在HER2阳性晚期实体瘤患者中的免疫原性。
剂量扩展阶段:一、主要研究目的:1)评价EX101注射液以推荐剂量在HER2阳性晚期乳腺癌和HER2阳性晚期胃癌/胃食管交界处腺癌患者中的安全性、耐受性;2)评价EX101注射液以推荐剂量在HER2阳性晚期乳腺癌和HER2阳性晚期胃癌/胃食管交界处腺癌患者中的有效性。二、次要研究目的:1)评价EX101注射液在HER2阳性晚期乳腺癌和HER2阳性晚期胃癌/胃食管交界处腺癌患者中的免疫原性。
[Translation] Dose escalation phase: 1. Main study objectives: 1) Evaluate the safety and tolerability of EX101 injection in patients with HER2-positive advanced solid tumors; 2) Explore dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) or the recommended dose (RP2D) for Phase II clinical trials. 2. Secondary study objectives: 1) Evaluate the pharmacokinetic characteristics of EX101 injection in patients with HER2-positive advanced solid tumors; 2) Evaluate the preliminary efficacy of EX101 injection in patients with HER2-positive advanced solid tumors; 3) Evaluate the immunogenicity of EX101 injection in patients with HER2-positive advanced solid tumors.
Dose expansion phase: 1. Main study objectives: 1) Evaluate the safety and tolerability of EX101 injection at the recommended dose in patients with HER2-positive advanced breast cancer and HER2-positive advanced gastric cancer/gastroesophageal junction adenocarcinoma; 2) Evaluate the efficacy of EX101 injection at the recommended dose in patients with HER2-positive advanced breast cancer and HER2-positive advanced gastric cancer/gastroesophageal junction adenocarcinoma. 2. Secondary study objectives: 1) To evaluate the immunogenicity of EX101 injection in patients with HER2-positive advanced breast cancer and HER2-positive advanced gastric cancer/gastroesophageal junction adenocarcinoma.
100 Clinical Results associated with EX-101
100 Translational Medicine associated with EX-101
100 Patents (Medical) associated with EX-101
100 Deals associated with EX-101