评估注射用多西他赛聚合物胶束在晚期恶性实体瘤患者中有效性和安全性的开放性、多队列II期临床研究
[Translation] An open-label, multi-cohort phase II clinical study to evaluate the efficacy and safety of docetaxel polymer micelles for injection in patients with advanced malignant solid tumors
1. 剂量确认阶段:评估HT001三种给药方案在晚期食管癌患者中的安全性及耐受性,确定后续推荐给药方案;
2. 队列拓展阶段:评估HT001在晚期实体瘤患者中的疗效;
[Translation] 1. Dose confirmation phase: evaluate the safety and tolerability of three dosing regimens of HT001 in patients with advanced esophageal cancer and determine the subsequent recommended dosing regimen;
2. Cohort expansion phase: evaluate the efficacy of HT001 in patients with advanced solid tumors;
评估注射用多西他赛聚合物胶束在晚期恶性实体瘤患者的耐受性和药代动力学特征的 I 期临床研究
[Translation] A phase I clinical study to evaluate the tolerability and pharmacokinetic characteristics of docetaxel polymer micelles for injection in patients with advanced malignant solid tumors
1. 评价注射用多西他赛聚合物胶束在晚期恶性实体瘤患者的安全性和耐受性。 2. 比较注射用多西他赛聚合物胶束与泰索帝注射液的 PK 相似性。 3. 获取注射用多西他赛聚合物胶束在晚期恶性实体瘤患者的药代动力学参数。 4. 比较注射用多西他赛聚合物胶束与泰索帝注射液的安全性。 5. 初步观察注射用多西他赛聚合物胶束的抗肿瘤疗效。
[Translation] 1. To evaluate the safety and tolerability of docetaxel polymer micelles for injection in patients with advanced malignant solid tumors. 2. To compare the PK similarity between docetaxel polymer micelles for injection and taxotere injection. 3. To obtain the pharmacokinetic parameters of docetaxel polymer micelles for injection in patients with advanced malignant solid tumors. 4. To compare the safety of docetaxel polymer micelles for injection and taxotere injection. 5. To preliminarily observe the anti-tumor efficacy of docetaxel polymer micelles for injection.
100 Clinical Results associated with Suzhou Hightechbio Biotechnology Co. Ltd.
0 Patents (Medical) associated with Suzhou Hightechbio Biotechnology Co. Ltd.
100 Deals associated with Suzhou Hightechbio Biotechnology Co. Ltd.
100 Translational Medicine associated with Suzhou Hightechbio Biotechnology Co. Ltd.