Safety, Tolerability and Pharmacokinetics of MORAb-003 in Subjects With Advanced Ovarian Cancer

Inclusion criteria

• Female subjects, ≥18 years of age, with a histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal adenocarcinoma, with or without elevation of CA 125, confirmed at the Department of Pathology, Memorial Sloan-Kettering Cancer Center.
• 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 CA-125, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
• Subject must have failed at least a standard (platinum-containing) chemotherapy regimen and be considered platinum refractory or resistant.
• Life expectancy ≥3 months, as estimated by the investigator.
• Karnofsky performance status ≥70%.
• Subjects must be surgically sterile, postmenopausal, or using an effective form of contraception.
• Subjects undergoing treatment with other medications must have been on a stable medication regimen 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 ≥10 g/dL Serum bilirubin ≤2.0 mg/dL Aspartate transaminase (AST) ≤2.5 x upper limit of normal (ULN) Alanine transaminase (ALT) ≤2.5 x ULN Serum creatinine ≤2.0 mg/dL Amylase ≤1.5 x ULN Lipase ≤1.5 x ULN

• Spirometry indicating a FEV1 of >79% of predicted.
• 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.
• Active asthma or other chronic lung disease.
• 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.
• Chronic inflammatory bowel disease.
• Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment.
• Breast-feeding, pregnant, or likely to become pregnant during the study.
• Active hepatitis or HIV infection.
• Subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or documented HAHA.
• Subjects with large ascites (≥500 cc based on results of most recent CT scan).