[Translation] Phase I clinical study of safety, tolerability, pharmacokinetics and preliminary efficacy of WBC100 capsules in patients with C-Myc positive solid tumors
主要目的:
评估WBC100胶囊在C-Myc阳性晚期实体瘤患者中的安全性和耐受性;
确定WBC100胶囊在C-Myc阳性晚期实体瘤患者中的剂量限制性毒性(DLT)和最大耐受剂量(MTD)。
次要目的:
评价WBC100胶囊在C-Myc阳性晚期实体瘤患者中的药代和药效动力学特征;
按照实体瘤疗效评价标准(RECIST v1.1),评估WBC100胶囊在C-Myc阳性胰腺癌患者中的初步抗肿瘤活性;
探索II期推荐剂量(RP2D)。
[Translation] main purpose:
To evaluate the safety and tolerability of WBC100 capsules in patients with C-Myc-positive advanced solid tumors;
To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of WBC100 capsules in patients with C-Myc-positive advanced solid tumors.
Secondary purpose:
To evaluate the pharmacokinetics and pharmacodynamics of WBC100 capsules in patients with C-Myc-positive advanced solid tumors;
To evaluate the preliminary antitumor activity of WBC100 capsules in patients with C-Myc positive pancreatic cancer according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
Explore Phase II Recommended Dosing (RP2D).