A Study of MORAb-003 in Patients With Solid Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MORAb-003

Group Type EXPERIMENTAL

MORAb-003

Intervention Type DRUG

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

Interventions

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MORAb-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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No