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

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