Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma

MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein,
which is expressed on cells involved in tumor vasculature. Studies have found endosialin to
play a key role in tumor growth and neovessel formation in numerous cancer types including
melanoma. Preclinical pharmacological studies have shown that MORAb-004 is a potentially
useful anti-cancer agent. This clinical trial is being performed to determine the efficacy of
MORAb-004 at two dose levels in subjects with metastatic melanoma, as well as to establish
serum pharmacokinetics and pharmacodynamics of the antibody.

Inclusion Criteria:

- Histologically confirmed diagnosis of metastatic melanoma

- At least one prior line of systemic treatment with confirmed progression of disease

- Measurable disease, as defined by RECIST, assessed within 4 wks prior to study entry

- At least 3 week interval between first infusion of test article and most recent prior
systemic anticancer therapy

- ECOG Performance Status of 0 or 1

Exclusion Criteria:

- Evidence of other active malignancy requiring treatment within the last 5 years (other
than basal cell or squamous cell carcinoma of the skin), or active brain metastasis

- Clinically significant heart disease (Congestive heart failure of NYHA Class 3 or 4,
angina not well controlled by medication, or myocardial infarction within 6 mos.), or
ECGs demonstrating clinically significant arrhythmias

- Brain metastasis

- Known allergic reaction to a prior monoclonal antibody therapy

- Previous treatment with MORAb-004