A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors

Inclusion Criteria:

- Subjects ≥18 years of age.

- Subjects with any malignant solid tumor without intracranial involvement or
metastases diagnosed by standard pathology criteria that has failed standard
chemotherapy.

- Subject must have disease, as defined by 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.

- Karnofsky performance status ≥70%.

- 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 30
days after MORAb-004 administration. A barrier method of contraception must be
included.

- 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 ULN; or ≤5
x ULN if liver metastases are present; Alanine transaminase (ALT) ≤2.5 x ULN; or ≤5 x
ULN if liver metastases are present; Serum creatinine ≤2.0 mg/dL; prothrombin time
(PT) and aPTT within institutional limits of normal.

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

- In Part 2 (expansion cohorts) ONLY, subjects must have a histological diagnosis of
either CRC or STS (and subtypes, excluding bone sarcomas).

Exclusion Criteria:

- Known central nervous system (CNS) tumor involvement or metastases.

- Evidence of other active malignancy.

- 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).

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

- Presence of severe lung disease (In the absence of clinically apparent severe lung
disease, no formal testing is necessary. In the presence of clinically severe lung
disease, FEV1 must be >60% in order for the subject to be eligible.)

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

- Chronic inflammatory disorder, e.g., inflammatory bowel disease, active vasculitis.

- 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 human immunodeficiency virus (HIV) infection.

- Subjects who have received a previous monoclonal antibody therapy and have evidence
of an immune or allergic reaction, or previously documented human anti-human antibody
(HAHA).

- Subjects with large ascites or pleural effusion (≥500 cc) based on results of most
recent CT scan).

- Chronic systemic anticoagulation therapy with warfarin or heparin