[Translation] A phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of HSK42360 tablets in patients with advanced solid tumors with BRAF V600 mutations
主要目的:
评价HSK42360片在BRAF V600突变晚期实体瘤患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HSK42360片在BRAF V600突变晚期实体瘤患者中的药代动力学特征;
初步评价HSK42360片在BRAF V600突变晚期实体瘤患者中的疗效。
探索性目的:
评价肿瘤组织(或血液或脑脊液)样本中生物标志物特征和脑脊液中药物浓度,以及与HSK42360片疗效的关系。
[Translation] Primary purpose:
To evaluate the safety and tolerability of HSK42360 tablets in patients with advanced solid tumors with BRAF V600 mutations; to determine the recommended dose (RP2D) for Phase II clinical trials.
Secondary purpose:
To evaluate the pharmacokinetic characteristics of HSK42360 tablets in patients with advanced solid tumors with BRAF V600 mutations;
To preliminarily evaluate the efficacy of HSK42360 tablets in patients with advanced solid tumors with BRAF V600 mutations.
Exploratory purpose:
To evaluate the biomarker characteristics in tumor tissue (or blood or cerebrospinal fluid) samples and the drug concentration in cerebrospinal fluid, and their relationship with the efficacy of HSK42360 tablets.