[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.