A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer

Inclusion Criteria:

- Males and females ≥ 18 years of age

- Histologically or cytologically confirmed advanced solid tumor malignancy, refractory
or relapsed from prior therapy, or for whom no alternative therapy is available

- At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents,
whichever is shorter), radiotherapy, major surgery or experimental treatment and
recovered from all acute toxicities (≤ Grade 1)

- Archival tumor sample available, or be willing to undergo a fresh tumor biopsy, prior
to study

- At least one measurable disease site that meets target lesion requirements

- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2

- Life expectancy of ≥ 3 months

- Adequate hematologic parameters without ongoing transfusional support:

- Negative serum pregnancy test

- Ability to provide written informed consent

- Expansion Phase: P-cadherin positive tumor expression

Exclusion Criteria:

- Previous radioimmunotherapy. Previous antibody-based therapy is allowed as long as ≥
28 days has elapsed from last dose to study treatment.

- Prior radiation to > 30% of the red marrow or to maximal tolerable level for any organ

- Serious cardiac condition within the last 6 months

- Concomitant medication(s) that may cause QTc prolongation or induce Torsades de
Pointes, with the exception of antimicrobials that are considered to be essential for
care of the patient

- History of retinal degenerative disease, history of uveitis, history of retinal vein
occlusion (RVO), or any eye condition that would be considered a risk factor for RVO
or has medically relevant abnormalities identified on screening ophthalmologic
examination

- Active central nervous system (CNS) malignant disease in subjects with a history of
CNS malignancy. Subjects with stable, prior, or currently treated brain metastases are
allowed.

- Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface
antigen (HBsAg) or hepatitis C virus (HCV)

- Known autoimmune disease

- Active infection requiring intravenous (IV) antibiotic usage within the last week
prior to the dosimetry portion of the study

- Corticosteroid use within 2 weeks of study treatment

- Any other medical intervention or other condition which, in the opinion of the
Principal Investigator, could compromise adherence with study requirements or confound
the interpretation of study results

- Pregnant or breast-feeding