[Translation] A Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of HSK41959 tablets in patients with advanced solid tumors with MTAP deletion
主要目的:
评价HSK41959 片在MTAP缺失的晚期实体瘤受试者中的安全性和耐受性;确定 II 期临床试验推荐剂量(RP2D)。
次要目的:
评价HSK41959 片在MTAP缺失的晚期实体瘤受试者中的药代动力学特征;
初步评价HSK41959 片在MTAP缺失的晚期实体瘤受试者中的疗效。
探索性目的:
评价MTAP 缺失的晚期实体瘤受试者血液中SDMA浓度的变化。
[Translation] Primary purpose:
Evaluate the safety and tolerability of HSK41959 tablets in subjects with advanced solid tumors with MTAP deletion; determine the recommended dose (RP2D) for Phase II clinical trials.
Secondary purpose:
Evaluate the pharmacokinetic characteristics of HSK41959 tablets in subjects with advanced solid tumors with MTAP deletion;
Preliminary evaluation of the efficacy of HSK41959 tablets in subjects with advanced solid tumors with MTAP deletion.
Exploratory purpose:
Evaluate the changes in SDMA concentration in the blood of subjects with advanced solid tumors with MTAP deletion.