A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 319 in Adult Subjects With Relapsed or Refractory Lymphoid Malignancies

Inclusion Criteria:

- Part 1 (Dose Exploration): Relapsed or refractory lymphoid malignancy of the following
type for which standard treatment does not exist or is no longer effective:

B-cell Chronic Lymphocytic Leukemia (CLL) confirmed by immunophenotype or Non-Hodgkin
Lymphoma: Low or intermediate grade B-cell NHL, mantle cell lymphoma, non-cutaneous T-cell
NHL confirmed by histology and/or immunophenotype

- Part 2 (Dose Expansion): Subjects must have relapsed or refractory B-cell Chronic
Lymphocytic Leukemia confirmed by immunophenotype for which standard treatment does
not exist or is no longer effective.

- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

- Life expectancy of > 3 months, in the opinion of the investigator

- Men or women ≥ 18 years old

- Hematological function, as follows:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (unless due to disease-related bone marrow
involvement as documented by bone marrow biopsy, ≥ 0.5 x 109/L) Platelet count ≥ 50 x
109/L (without a transfusion within 14 days before enrollment) Hemoglobin ≥ 9 g/dL

- Hepatic function, as follows: Aspartate aminotransferase (AST) < 3.0 x ULN Alanine
aminotransferase (ALT) < 3.0 x ULN Alkaline phosphatase (ALP) < 2.0 x ULN (< 5 x ULN in
subjects whom the PI and sponsor agree that clinical data suggest an extrahepatic source
of elevation) Total bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented
Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source
of elevation) Amylase ≤ 2.0 x IULN Lipase ≤ 2.0 x IULN

Exclusion Criteria:

- Primary or disseminated tumor involving the central nervous system (CNS)

- A history of other malignancies, except: adequately treated non-melanoma skin cancer,
curatively treated in-situ cancer, or other solid tumors curatively treated with no
evidence of disease for ≥ 2 years

- History of allogeneic stem-cell (or other organ) transplantation

- Clinically significant ECG changes which obscure the ability to assess the PR, QT,
and QRS interval; congenital long QT syndrome

- QTcF interval > 470 msec

- Active or chronic hepatitis B or hepatitis C infection, determined by serologic tests

- Recent infection requiring intravenous anti-infective treatment that was completed ≤
14 days before enrollment