[Translation] A single-arm, open-label, dose-escalation and expansion phase I clinical study of RMX1002 in patients with advanced solid tumors to evaluate its pharmacokinetics, tolerability and preliminary efficacy
主要目的: 评价RMX1002片多次口服给药治疗晚期实体瘤患者的安全性及耐受性,确定最大耐受剂量、II期推荐剂量及给药方案。 次要目的: 1.评价RMX1002片在晚期实体瘤患者体内的PK特征; 2.初步观察RMX1002片在晚期实体瘤患者中的初步疗效。 探索性目的: 初步探索药效动力学指标与疗效的潜在关系。
[Translation] Primary purpose: To evaluate the safety and tolerability of multiple oral administration of RMX1002 tablets in patients with advanced solid tumors, and to determine the maximum tolerated dose, Phase II recommended dose, and dosing regimen. Secondary purpose: 1. To evaluate the PK characteristics of RMX1002 tablets in patients with advanced solid tumors; 2. To preliminarily observe the preliminary efficacy of RMX1002 tablets in patients with advanced solid tumors. Exploratory purpose: To preliminarily explore the potential relationship between pharmacodynamic indicators and efficacy.