[Translation] A multicenter, open-label, phase Ib/IIa study to evaluate the efficacy, safety, and pharmacokinetic characteristics of DC05F01 in patients with advanced solid tumors such as relapsed/refractory ovarian cancer
主要目的: 评价DC05F01在复发/难治性卵巢癌等晚期实体瘤患者中的疗效。
次要目的:(1)评价DC05F01在复发/难治性卵巢癌等晚期实体瘤患者中的安全性和耐受性。(2)评价DC05F01在复发/难治性卵巢癌等晚期实体瘤患者中的药代动力(PK)特征。
探索性目的: (1)探索潜在生物标志物Fascin蛋白的表达水平与DC05F01抗肿瘤疗效的相关性。(2)探索卵巢癌患者血液中CA125与疗效及预后的相关性。
[Translation] Primary objective: To evaluate the efficacy of DC05F01 in patients with advanced solid tumors such as relapsed/refractory ovarian cancer.
Secondary objectives: (1) To evaluate the safety and tolerability of DC05F01 in patients with advanced solid tumors such as relapsed/refractory ovarian cancer. (2) To evaluate the pharmacokinetic (PK) characteristics of DC05F01 in patients with advanced solid tumors such as relapsed/refractory ovarian cancer.
Exploratory objectives: (1) To explore the correlation between the expression level of Fascin protein, a potential biomarker, and the anti-tumor efficacy of DC05F01. (2) To explore the correlation between CA125 in the blood of patients with ovarian cancer and the efficacy and prognosis.