[Translation] A first-in-human, open-label Phase I study to evaluate the safety, pharmacokinetics, and anti-tumor activity of SIM0501 as monotherapy and in combination therapy in subjects with advanced solid tumors
主要目的:
第1部分:评价SIM0501单药治疗的安全性和耐受性,并确定最大耐受剂量1(maximum tolerated dose 1, MTD1)和/或推荐剂量1(recommended dose 1, RD1);
第2部分:评价SIM0501联合奥拉帕利的安全性和耐受性,并确定MTD2和/或RD2;
次要目的:
进一步评价SIM0501单药治疗和与奥拉帕利联合治疗的安全性和耐受性特征;
评价SIM0501单药治疗和与奥拉帕利联合治疗的药代动力学(pharmacokinetics, PK)特征;
评价SIM0501单药治疗和与奥拉帕利联合治疗的初步抗肿瘤活性。
[Translation] Primary objectives:
Part 1: To evaluate the safety and tolerability of SIM0501 monotherapy and determine the maximum tolerated dose 1 (MTD1) and/or recommended dose 1 (RD1);
Part 2: To evaluate the safety and tolerability of SIM0501 combined with olaparib and determine MTD2 and/or RD2;
Secondary objectives:
To further evaluate the safety and tolerability characteristics of SIM0501 monotherapy and combination therapy with olaparib;
To evaluate the pharmacokinetic (PK) characteristics of SIM0501 monotherapy and combination therapy with olaparib;
To evaluate the preliminary anti-tumor activity of SIM0501 monotherapy and combination therapy with olaparib.