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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date08 Jun 2021 |
评价注射用维迪西妥单抗治疗HER-2表达的局部晚期或转移性去势抵抗性前列腺癌受试者的安全性、有效性及药代动力学特征的多中心、II期临床研究
[Translation] A multicenter, phase II clinical study to evaluate the safety, efficacy, and pharmacokinetic characteristics of vedicizumab injection in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer expressing HER-2
主要目的:
评价维迪西妥单抗治疗局部晚期或转移性去势抵抗性前列腺癌受试者的有效性。
次要目的:
评价维迪西妥单抗在局部晚期或转移性去势抵抗性前列腺癌受试者中安全性和耐受性; 评价维迪西妥单抗在局部晚期或转移性去势抵抗性前列腺癌受试者中的药代动力学(PK) 特征和免疫原性。
[Translation] Primary objective:
To evaluate the efficacy of vedicizumab in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.
Secondary objectives:
To evaluate the safety and tolerability of vedicizumab in subjects with locally advanced or metastatic castration-resistant prostate cancer; To evaluate the pharmacokinetic (PK) characteristics and immunogenicity of vedicizumab in subjects with locally advanced or metastatic castration-resistant prostate cancer.
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