SH3765片在晚期恶性肿瘤患者中单、多次剂量递增的安全性、耐受性及药代动力学的I期临床研究。
[Translation] A phase I clinical study on the safety, tolerability and pharmacokinetics of single and multiple ascending doses of SH3765 tablets in patients with advanced malignant tumors.
主要目的:评价SH3765片单、多次给药在晚期恶性肿瘤患者中的安全性和耐受性,确定剂量限制性毒性(DLT)和最大耐受剂量(MTD)。
次要目的:研究SH3765片的药代动力学特征;初步评估SH3765片治疗晚期恶性肿瘤患者的疗效,为确定II期临床推荐剂量提供依据。
探索性目的:探索SH3765片治疗晚期恶性肿瘤患者的生物标志物。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple administrations of SH3765 tablets in patients with advanced malignant tumors, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
Secondary objective: To study the pharmacokinetic characteristics of SH3765 tablets; to preliminarily evaluate the efficacy of SH3765 tablets in the treatment of patients with advanced malignant tumors, and to provide a basis for determining the recommended dose for Phase II clinical trials.
Exploratory objective: To explore biomarkers of SH3765 tablets in the treatment of patients with advanced malignant tumors.
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