[Translation] An open, multicenter, Phase I clinical study to evaluate the safety, efficacy, and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1, or ALK gene fusion mutations
Ia期-主要目的:评价SIM1803-1A 的安全性和耐受性;评价SIM1803-1A 的药代动力学特征;确定SIM1803-1A 的最大耐受剂量(MTD)和后续研究的合适推荐剂量(RD)。次要目的:初步评价SIM1803-1A 治疗NTRK、ROS1 或ALK 基因融合突变的局部晚期/转移性实体瘤患者的有效性。
Ib期-主要目的:评价SIM1803-1A 治疗NTRK、ROS1 或ALK 基因融合突变的局部晚期/转移性实体瘤患者的有效性。次要目的:评价SIM1803-1A 治疗NTRK、ROS1 或ALK 基因融合突变的局部晚期/转移性实体瘤患者的安全性;评价Ⅰa 期推荐剂量下SIM1803-1A 的药代动力学特征。
[Translation] Phase Ia-Primary purpose: To evaluate the safety and tolerability of SIM1803-1A; To evaluate the pharmacokinetic characteristics of SIM1803-1A; To determine the maximum tolerated dose (MTD) of SIM1803-1A and the appropriate recommended dose (RD) for subsequent studies. Secondary purpose: To preliminarily evaluate the effectiveness of SIM1803-1A in treating patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations.
Phase Ib-Primary purpose: To evaluate the effectiveness of SIM1803-1A in treating patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. Secondary purpose: To evaluate the safety of SIM1803-1A in treating patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations; To evaluate the pharmacokinetic characteristics of SIM1803-1A at the recommended dose of Phase Ia.