Study of 124I-NM404 in Advanced Solid Malignancies

124I-NM404 is a new investigational agent being developed to better identify local tumors
and cancerous tumors using imaging technologies such as positron emission tomography (PET)
scans. An investigational drug is a drug that has not been approved by the Food and Drug
Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by
the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed
tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more
accurately see and evaluate cancerous tumors. This agent has been safely studied in animals
and a limited number of human patients with lung cancer. This study is being done to
determine the best dose to use and to fully evaluate the images that result from using this
new agent.

Inclusion Criteria:

- Diagnosis of advanced solid malignancy.

- Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian,
pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer

- Disease must be at least 1cm in diameter

- Brain metastasis must be stable for at least one month.

- ECOG performance status 0-2

- Anticipated survival less than 5 years, as per the treating physician

Exclusion Criteria:

- Skin lesions only

- Chemotherapy or radiotherapy within 1 week

- Residual toxicities of grade 2 or greater from prior therapy

- Adequate organ function as per specified laboratory parameter

- Platelet count > or = to 75,000/uL