A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

Preexisting sensory and/or motor neuropathy Grade ≥ 2

Small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 2 weeks before first dose of study drug

Radioimmunotherapy within 4 weeks before first dose of study drug

Use of any investigational drug (including marketed drugs not approved for this indication) within 14 days prior to the first dose of study drug

Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 2 weeks before the first dose of study drug (See Appendix F for list of excluded drugs)

Anti Graft-Versus-Host Disease (GVHD) therapy within 12 weeks before the first dose of study drug

Platelet transfusion within 2 weeks and RBC transfusion within 4 days before the first dose of study drug

Known central nervous system (CNS) disease

History of other primary malignancy (including myeloid malignancy, e.g., myelodysplastic syndrome), unless

* Curatively resected nonmelanomatous skin cancer

* Other malignancy curatively treated with no known active disease present and no systemic treatment administered for 3 years before the first dose of study drug

Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of the first dose of study drug, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by outpatient medication

Women who are pregnant or lactating

Known HIV positive or AIDS

Positive Hepatitis B surface antigen test

Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy

Known sensitivity to any of the components of the investigational product AGS67E:

* AGS67E

* L-Histidine

* α-trehalose dihydrate or

* polysorbate 20

History of thromboembolic events (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) ≤ 2 weeks before the first dose of study drug and/or clinical diffuse intravascular coagulation (DIC)

Active infection requiring treatment ≤7 days before the first dose of study drug

Condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study

Any medical, psychiatric, addictive or other disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures.

What this study is about