A Study of MORAb-009 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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Mesothelin-positive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MORAb-009

Group Type EXPERIMENTAL

MORAb-009

Intervention Type DRUG

MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.

Interventions

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MORAb-009

MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No