A Study of MORAb-009 in Patients With Solid Tumor

A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.

Inclusion criteria;

1. Japanese male and female patients aged from 20 to less than 80 years at obtaining informed consent
2. Patient with histologically or cytologically diagnosed solid tumor
3. Patient who is mesothelin-positive confirmed by immunohistochemistry (IHC) (except for pancreatic cancer and mesothelioma that mesothelin-positive is frequently reported)
4. Patient with solid tumor who is non responder to or resistant to standard therapy and has no other appropriate treatment
5. Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group ECOG criteria

Exclusion criteria

1. Brain metastasis presenting clinical symptoms or requiring medical treatment
2. Serious and systemic infection requiring medical treatment
3. History of hypersensitivity to protein formulations including monoclonal antibody
4. With active multiple carcinoma (except for carcinoma in situ and intramucosal carcinoma)
5. With celomic fluid (pleural effusion or ascites) uncontrolled by drainage, or with a large volume of celomic fluid