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A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-009, a Chimeric Monoclonal Antibody, in Subjects With Advanced Mesothelin-Expressing Tumors

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer, Mesothelioma, Ovarian Cancer, Non-Small Cell Lung Cancer

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Trial Information

A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-009, a Chimeric Monoclonal Antibody, in Subjects With Advanced Mesothelin-Expressing Tumors

MORAb-009 is a high-affinity monoclonal antibody raised against human mesothelin, a membrane
glycoprotein thought to be involved in cell adhesion and tightly associated with a range of
cancers. It has been shown that mesothelin is over-expressed in pancreatic cancers,
mesotheliomas, and ovarian or mesothelin-expressing ovarian or non-small cell lung cancers,
while showing little expression in normal tissues. Preclinical experiments indicate that
MORAb-009 is a potentially useful anti-cancer agent. This clinical trial is being performed
to determine the safety of MORAb-009 in subjects with mesothelin-expressing tumors, as well
as to establish serum pharmacokinetics of the antibody, and to assess tumor antigens that
may serve as predictors of a response to MORAb-009.

Inclusion Criteria:

- Female or male subjects, ≥ 18 years of age, with a histologically confirmed diagnosis
of pancreatic adenocarcinoma, mesothelioma, or mesothelin-positive ovarian or
non-small cell lung cancer. As nearly 100% of pancreatic adenocarcinoma and
mesotheliomas express mesothelin, immunohistochemical confirmation of
mesothelin-positivity is not necessary.

- Subject must have disease, as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or
lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies
conducted within 4 weeks prior to study entry.

- Subject must have failed at least one standard chemotherapy regimen. Patients with
pancreatic cancer must have received gemcitabine as part of prior therapy and be
considered refractory, or in the case of ovarian cancer be considered platinum
refractory or resistant.

- Life expectancy ≥ 3 months, as estimated by the investigator.

- Eastern Cooperative Oncology Group performance status or 0, 1 or 2.

- Female subjects of childbearing potential and all male subjects must consent to use a
medically acceptable method of contraception throughout the study period and for 28
days after MORAb-009 administration. A barrier method of contraception must be

- Other significant medical conditions must be well controlled and stable in the
opinion of the investigator for at least 30 days prior to Study Day 1.

- Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 100 x 109/L; Hemoglobin ≥
9 g/dL; Serum bilirubin ≤ 2.0 mg/dL; Aspartate transaminase (AST) ≤ 5 x upper limit of
normal (ULN); Alanine transaminase (ALT) ≤ 5 x ULN; Alkaline Phosphatase ≤ 5 x ULN; Serum
creatinine ≤ 2.0 mg/dL. If the elevations of liver functions are due to obstruction of the
common bile duct extrinsic to the liver, the subject may be enrolled at the discretion of
the investigator even if the elevations are greater than the limits above. Stenting to
reduce liver functions to qualifying levels is permitted.

- Subject must be willing and able to provide written informed consent.

Exclusion Criteria:

- Known central nervous system (CNS) tumor involvement.

- Evidence of other active malignancy requiring treatment.

- Clinically significant heart disease (e.g., congestive heart failure of New York
Heart Association Class III or IV, angina not well controlled by medication, or
myocardial infarction within 6 months).

- ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic
atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).

- Active serious systemic disease, including active bacterial or fungal infection.

- Active hepatitis or HIV infection.

- Treatment within three months with immunomodulatory therapy (e.g. interferons,
immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term systemic
corticosteroids or topical or intra-articular steroids are acceptable, subject to the
judgment of the investigator.

- Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to dosing with

- Breast-feeding, pregnant, or likely to become pregnant during the study.

Type of Study:


Study Design:

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

Outcome Measure:


Principal Investigator

Susan C. Weil, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

September 2008

Related Keywords:

  • Pancreatic Cancer
  • Mesothelioma
  • Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer
  • Mesothelioma
  • Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Mesothelin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Mesothelioma
  • Ovarian Neoplasms
  • Pancreatic Neoplasms



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231
National Cancer InstituteBethesda, Maryland  20892-1922