A Study of MORAb-003 in Patients With Solid Tumor

Eisai

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Neoplasms

Treatments: Drug: MORAb-003

Study type: Interventional

Funder types: Industry

Identifiers

NCT01049061

MORAB-003-J081-102

Details and patient eligibility

About

MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.

Enrollment: 16 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria;

1. Japanese male and female aged >or=20 to <80 years at obtaining informed consent
2. Patient with histologically or cytologically diagnosed solid tumor
3. Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported)
4. Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have 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 other active malignancy (except for carcinoma in situ)
5. With a large volume of pleural effusion or ascites requiring drainage

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

MORAb-003

Experimental group

Treatment:

Drug: MORAb-003