[Translation] A multicenter, dose-escalation and cohort expansion, single-arm, open-label Phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic characteristics and preliminary anti-tumor efficacy of MT-001 capsules in patients with locally advanced/metastatic solid tumors
I期主要目的:评价MT-001胶囊的安全性和耐受性,确定最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。次要目的:评价MT-001胶囊的药代动力学特征及代谢物谱;评价MT-001胶囊的药效动力学特征,以及药代动力学/药效动力学相关性;初步探索MT-001胶囊的抗肿瘤疗效。探索性终点:生物标志物探索性研究。
IIa期主要目的:评价MT-001胶囊在II期推荐剂量(RP2D)下的安全性和耐受性;评价MT-001胶囊在II期推荐剂量(RP2D)下的初步抗肿瘤疗效。次要目的:评价MT-001胶囊在II期推荐剂量(RP2D)下的抗肿瘤疗效;评价MT-001胶囊在II期推荐剂量(RP2D)下的药代动力学特征;药效动力学特征,以及药代动力学/药效动力学相关性。探索性终点:生物标志物探索性研究。
[Translation] The main purpose of Phase I is to evaluate the safety and tolerability of MT-001 capsules and determine the maximum tolerated dose (MTD) and/or Phase II recommended dose (RP2D). Secondary objectives are to evaluate the pharmacokinetic characteristics and metabolite profile of MT-001 capsules; evaluate the pharmacodynamic characteristics of MT-001 capsules, as well as the pharmacokinetic/pharmacodynamic correlation; and preliminarily explore the anti-tumor efficacy of MT-001 capsules. Exploratory endpoints: biomarker exploratory studies.
The main purpose of Phase IIa is to evaluate the safety and tolerability of MT-001 capsules at the Phase II recommended dose (RP2D); evaluate the preliminary anti-tumor efficacy of MT-001 capsules at the Phase II recommended dose (RP2D). Secondary objectives are to evaluate the anti-tumor efficacy of MT-001 capsules at the Phase II recommended dose (RP2D); evaluate the pharmacokinetic characteristics of MT-001 capsules at the Phase II recommended dose (RP2D); pharmacodynamic characteristics, and pharmacokinetic/pharmacodynamic correlation. Exploratory endpoints: biomarker exploratory studies.