[Translation] A Phase I/II study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of oral KBP-2205 monotherapy in subjects with advanced malignant solid tumors
主要目的:
评价多剂量KBP-2205在晚期恶性实体瘤受试者中的安全性和耐受性
确定最大耐受剂量(MTD)或最高给药剂量(MAD)
为II期推荐剂量(RP2D)提供依据
次要目的:
表征多剂量KBP-2205在晚期恶性实体瘤受试者中的药代动力学(PK)特征
观察KBP-2205治疗晚期实体瘤的初步抗肿瘤活性
研究KBP-2205对ECG QTc间期的影响,为后续评估潜在心脏毒性提供依据
探索性目的:
研究生物标志物的表达水平与KBP-2205的抗肿瘤活性间的关系,为后续临床试验中生物标志物的选择提供依据
研究KBP-2205暴露量与选定研究终点(如安全性与疗效)的关系
[Translation] Primary purpose:
Evaluate the safety and tolerability of multiple doses of KBP-2205 in subjects with advanced malignant solid tumors
Determine the maximum tolerated dose (MTD) or the highest dose (MAD)
Provide a basis for the Phase II recommended dose (RP2D)
Secondary purpose:
Characterize the pharmacokinetic (PK) characteristics of multiple doses of KBP-2205 in subjects with advanced malignant solid tumors
Observe the preliminary anti-tumor activity of KBP-2205 in the treatment of advanced solid tumors
Study the effect of KBP-2205 on the ECG QTc interval to provide a basis for the subsequent evaluation of potential cardiac toxicity
Exploratory purpose:
Study the relationship between the expression level of biomarkers and the anti-tumor activity of KBP-2205 to provide a basis for the selection of biomarkers in subsequent clinical trials
Study the relationship between KBP-2205 exposure and selected study endpoints (such as safety and efficacy)