A Study of MORAb-009 in Patients With Solid Tumor

Eisai

Status and phase: Completed; Phase 1

Conditions: Mesothelin-positive; Cancer

Treatments: Drug: MORAb-009

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018784

MORAB-009-J081-102

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

MORAb-009

Experimental group

Treatment:

Drug: MORAb-009