[Translation] An open-label, dose-escalation Phase I clinical study to evaluate the safety, tolerability, efficacy, and pharmacodynamics of CUD002 injection in subjects with refractory/resistant recurrent ovarian cancer
主要目的:评价CUD002注射液在难治性/耐药复发性卵巢癌受试者中的安全性和耐受性,并确定最大耐受剂量/推荐扩展剂量;
次要目的:评价CUD002注射液在难治性/耐药复发性卵巢癌受试者中的药效动力学、免疫原性特征;
探索性目的:评估抗肿瘤疗效;分析肿瘤标记物与疗效指标的关系。
[Translation] Primary purpose: To evaluate the safety and tolerability of CUD002 injection in subjects with refractory/resistant recurrent ovarian cancer and determine the maximum tolerated dose/recommended extended dose;
Secondary purpose: To evaluate the pharmacodynamics and immunogenicity characteristics of CUD002 injection in subjects with refractory/resistant recurrent ovarian cancer;
Exploratory purpose: To evaluate the anti-tumor efficacy; to analyze the relationship between tumor markers and efficacy indicators.