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