[Translation] An open-label, multicenter, dose-escalation and dose-expansion phase Ia/Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of SV-1993 capsules in patients with advanced solid tumors.
主要目的
1. 评价SV-1993胶囊在晚期实体瘤患者中的安全性和耐受性。
2. 确定扩展推荐剂量(RDE)和/或2期推荐剂量(RP2D)。
3. 观察可能出现的SV-1993胶囊的剂量限制性毒性(DLT)。
4. 确定最大耐受剂量(MTD)。
次要目的 1. 评价SV-1993胶囊在晚期实体瘤患者中的药代动力学特征。
2. 评价SV-1993胶囊的初步抗肿瘤疗效。
探索性目的
1. 评价SV-1993胶囊在晚期实体瘤患者中的生物标志物特征。
2. 评价SV-1993胶囊在晚期实体瘤患者中的药代动力学(PK)/药效动力学(PD)特征。
[Translation] Primary Objectives:
1. To evaluate the safety and tolerability of SV-1993 capsules in patients with advanced solid tumors.
2. To determine the extended recommended dose (RDE) and/or the phase 2 recommended dose (RP2D).
3. To observe potential dose-limiting toxicities (DLTs) of SV-1993 capsules.
4. To determine the maximum tolerated dose (MTD).
Secondary Objectives:
1. To evaluate the pharmacokinetic characteristics of SV-1993 capsules in patients with advanced solid tumors.
2. To evaluate the preliminary antitumor efficacy of SV-1993 capsules.
Exploratory Objectives:
1. To evaluate the biomarker characteristics of SV-1993 capsules in patients with advanced solid tumors.
2. To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of SV-1993 capsules in patients with advanced solid tumors.