A phase 1 study of MORAb-004 in patients with solid tumor

Eisai Co., Ltd.0 个研究点目标入组 54 人开始时间: 2013年2月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Provide written informed consent,
•2. Japanese male and female subjects aged 20 or older at informed consent,
•3. Have malignant solid tumor, without intracranial involvement or metastasis diagnosed by standard pathology criteria that are resistant to standard chemotherapy,
•4. Performance status (PS) is 0-1 by Eastern Cooperative Oncology Group,
•5. With no carry-over effect and no adverse drug reaction of prior treatment which may affect the safety evaluation of MORAb-004 (except for Grade 1 or 2 neuropathy and alopecia),
•6. Survival expectation is 12 years or longer after starting MORAb-004 administration

•1. Have clinically, significant cardiovascular disease,
•2. Scheduled for laparotomic surgery due to trauma or other reasons for during the study,
•3. Have clinically significant hemorrhagic event or history, or event with high risk of hemorrhage,
•4. Receiving chronic systemic anticoagulation,
•5. Have evidence of other active invasive malignancy,
•6. Females who are lactating or pregnant at Screenint or Baseline

发起方