[Translation] Multicenter, dose escalation and cohort expansion single arm to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic characteristics and preliminary anti-tumor efficacy of MT-001 capsules in patients with locally advanced/metastatic solid tumors , open-label phase I/IIa clinical study
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 recommended phase II dose (RP2D). Secondary purpose: To evaluate the pharmacokinetic characteristics and metabolite profile of MT-001 capsules; to evaluate the pharmacodynamic characteristics and pharmacokinetics/pharmacodynamics correlation of MT-001 capsules; to initially explore MT-001 Antitumor efficacy of capsules. Exploratory endpoints: Exploratory biomarker studies.
The main purpose of Phase IIa: to evaluate the safety and tolerability of MT-001 capsules at the recommended Phase II dose (RP2D); to evaluate the preliminary anti-tumor efficacy of MT-001 capsules at the Phase II recommended dose (RP2D). Secondary purpose: To evaluate the anti-tumor efficacy of MT-001 capsules at the Phase II recommended dose (RP2D); to evaluate the pharmacokinetic characteristics and pharmacodynamic characteristics of MT-001 capsules at the Phase II recommended dose (RP2D), and pharmacokinetic/pharmacodynamic correlations. Exploratory endpoints: Exploratory biomarker studies.