Neoplasms, Solid Tumor
Conditions
Keywords
Cancer, FRα
Brief summary
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.
Interventions
DRUGMORAb-003
MORAb-003 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
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate dose-limiting toxicity and estimate maximum tolerated dose. | 7 weeks |
Countries
Japan
Outcome results
None listed