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A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

Phase 1
20 Years
79 Years
Not Enrolling
Cancer, Mesothelin-positive

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Trial Information

A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

Inclusion 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

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

5. With celomic fluid (pleural effusion or ascites) uncontrolled by drainage, or with a
large volume of celomic fluid

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To investigate dose-limiting toxicity and estimate maximum tolerated dose.

Outcome Time Frame:

4 Weeks

Safety Issue:


Principal Investigator

Chifumi Kitamura

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek Clinical Development Section, JAC PCU


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

November 2009

Completion Date:

May 2012

Related Keywords:

  • Cancer
  • Mesothelin-positive
  • Cancer
  • Mesothelin-positive