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Clinical Trials associated with AHT-102 / Not yet recruitingPhase 1 评估AHT-102注射液在CLDN18.2阳性晚期实体瘤患者中安全性和耐受性的临床Ⅰ期研究
[Translation] Phase I clinical study to evaluate the safety and tolerability of AHT-102 injection in patients with CLDN18.2-positive advanced solid tumors
主要目的:
评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者的安全性和耐受性;
确定AHT-102注射液的最大耐受剂量(MTD)和/或II期临床研究推荐剂量(RP2D)。
次要目的:
评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者的药代动力学(PK)特征;
评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者的免疫原性;
采用实体瘤疗效评价标准1.1版(RECISTV1.1)评估AHT-102注射液在CLDN18.2阳性晚期实体瘤受试者的初步抗肿瘤活性。
探索性目的:
采用免疫治疗实体瘤疗效评价标准(iRECIST)评估AHT-102注射液在CLDN18.2阳性晚期实体瘤受试者的初步抗肿瘤活性(仅RECISTV1.1评价为PD后采用iRECIST评价);
评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者的药效学(PD)特征;
在剂量扩展阶段,评估AHT-102注射液治疗CLDN18.2阳性晚期实体瘤受试者血液分子标志物水平的变化。
[Translation] Primary objectives:
To evaluate the safety and tolerability of AHT-102 injection in the treatment of subjects with CLDN18.2-positive advanced solid tumors;
To determine the maximum tolerated dose (MTD) and/or recommended dose (RP2D) of AHT-102 injection for Phase II clinical studies.
Secondary objectives:
To evaluate the pharmacokinetic (PK) characteristics of AHT-102 injection in the treatment of subjects with CLDN18.2-positive advanced solid tumors;
To evaluate the immunogenicity of AHT-102 injection in the treatment of subjects with CLDN18.2-positive advanced solid tumors;
To evaluate the preliminary anti-tumor activity of AHT-102 injection in subjects with CLDN18.2-positive advanced solid tumors using the Solid Tumor Efficacy Evaluation Criteria Version 1.1 (RECIST V1.1).
Exploratory purpose:
Use the immunotherapy efficacy evaluation criteria for solid tumors (iRECIST) to evaluate the preliminary anti-tumor activity of AHT-102 injection in subjects with CLDN18.2-positive advanced solid tumors (iRECIST evaluation is used only after RECISTV1.1 is evaluated as PD);
Evaluate the pharmacodynamic (PD) characteristics of AHT-102 injection in the treatment of subjects with CLDN18.2-positive advanced solid tumors;
In the dose expansion phase, evaluate the changes in the levels of blood molecular markers in subjects with CLDN18.2-positive advanced solid tumors treated with AHT-102 injection.
100 Clinical Results associated with AHT-102
100 Translational Medicine associated with AHT-102
100 Patents (Medical) associated with AHT-102
100 Deals associated with AHT-102