[Translation] A multicenter, open-label, phase Ia/Ib clinical study evaluating the safety, tolerability, and pharmacokinetics of cedarizumab in patients with advanced melanoma and urothelial carcinoma
主要目的
评价西达珠单抗在晚期黑色素瘤和尿路上皮癌患者中的安全性和耐受性;
确定西达珠单抗治疗晚期黑色素瘤和尿路上皮癌患者的最大耐受剂量(MTD)/推荐扩展剂量(RDE)。
次要目的
初步评价西达珠单抗的抗肿瘤活性;
评价西达珠单抗的药代动力学特征;
评价西达珠单抗的免疫原性。
探索目的
采用iRECIST标准(2017)探索性评价西达珠单抗的抗肿瘤活性;
探索西达珠单抗的药效学特征;
探索相关生物标志物与临床疗效的关系。
[Translation] Primary objective
To evaluate the safety and tolerability of cedarizumab in patients with advanced melanoma and urothelial carcinoma;
To determine the maximum tolerated dose (MTD)/recommended extended dose (RDE) of cedarizumab in the treatment of patients with advanced melanoma and urothelial carcinoma.
Secondary objective
To preliminarily evaluate the anti-tumor activity of cedarizumab;
To evaluate the pharmacokinetic characteristics of cedarizumab;
To evaluate the immunogenicity of cedarizumab.
Exploratory objective
To explore the anti-tumor activity of cedarizumab using the iRECIST criteria (2017);
To explore the pharmacodynamic characteristics of cedarizumab;
To explore the relationship between relevant biomarkers and clinical efficacy.