[Translation] A clinical study to evaluate the safety, tolerability, pharmacokinetics, efficacy and correlation with AKR1C3 enzyme expression of TFX05-01 in the treatment of subjects with advanced solid tumors.
主要目的:
评估晚期实体瘤受试者接受TFX05-01给药的安全性、耐受性;
确定TFX05-01单药治疗的最大耐受剂量(MTD)、Ⅱ期推荐剂量(RP2D);
确定TFX05-01单药治疗的给药方案;
次要目的:
评价TFX05-01在晚期实体瘤受试者体内药代动力学特征;
评价TFX05-01治疗晚期实体瘤受试者的初步疗效(客观缓解率ORR、疾病控制率DCR、无进展生存期PFS、缓解持续时间DoR、总生存期OS);
肿瘤组织AKR1C3表达情况(免疫组织化学检测)。
[Translation] Main purpose:
To evaluate the safety and tolerability of TFX05-01 in subjects with advanced solid tumors;
To determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of TFX05-01 monotherapy;
To determine the dosing regimen of TFX05-01 monotherapy;
Secondary purpose:
To evaluate the pharmacokinetic characteristics of TFX05-01 in subjects with advanced solid tumors;
To evaluate the preliminary efficacy of TFX05-01 in the treatment of subjects with advanced solid tumors (objective response rate ORR, disease control rate DCR, progression-free survival PFS, duration of response DoR, overall survival OS);
AKR1C3 expression in tumor tissues (immunohistochemistry detection).