[Translation] A single-arm, open-label, single/multiple-dose dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of WE011 for injection in patients with advanced solid tumors
主要研究目的: 剂量递增阶段: 1) 评价注射用 WE011 在晚期实体瘤患者中的安全性和耐受性; 2) 确定注射用 WE011 的最大耐受剂量(Maximum Tolerated Dose,MTD)。 剂量扩展阶段: 进一步确定注射用 WE011 在晚期实体瘤(包括但不限于乳腺癌和卵巢癌)患者中的安全性。 次要研究目的:
剂量递增阶段: 1) 评价注射用 WE011 在晚期实体瘤患者中的药代动力学特征; 2) 初步评价注射用 WE011 在晚期实体瘤患者中的抗肿瘤疗效。 剂量扩展阶段: 1) 评价注射用 WE011 在晚期实体瘤患者中的初步有效性; 2) 推荐 II 期剂量。
[Translation] Primary study objectives: Dose escalation phase: 1) Evaluate the safety and tolerability of WE011 for injection in patients with advanced solid tumors; 2) Determine the maximum tolerated dose (MTD) of WE011 for injection. Dose expansion phase: Further determine the safety of WE011 for injection in patients with advanced solid tumors (including but not limited to breast cancer and ovarian cancer). Secondary study objectives:
Dose escalation phase: 1) Evaluate the pharmacokinetic characteristics of WE011 for injection in patients with advanced solid tumors; 2) Preliminary evaluation of the anti-tumor efficacy of WE011 for injection in patients with advanced solid tumors. Dose expansion phase: 1) Evaluate the preliminary effectiveness of WE011 for injection in patients with advanced solid tumors; 2) Recommend Phase II dose.