A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma

Inclusion Criteria:

- Subjects must have a pathologically documented, definitively diagnosed, clear cell
RCC that is relapsed/refractory following at least two lines of systemic therapy (one
of which must be a tyrosine kinase), or the subject refuses standard therapy

- Measurable disease per RECIST 1.1 criteria. Subjects with non-measurable, but
evaluable disease are also eligible for Part 1 of the study.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

- Willing to provide tumor samples and / or slides

- Hematological function, as follows:

1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;

2. Platelet count ≥ 100 x 10^9/L;

3. Hemoglobin > 9 g/dL

- Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional
upper limit of normal (IULN)

- Hepatic function, as follows:

1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x ULN;

2. 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);

3. Alkaline phosphatase < 2 x ULN (< 5 x ULN in subjects whom the PI and sponsor
agree that clinical data suggest extrahepatic source of elevation)

- Other inclusion criteria may apply

Exclusion Criteria:

- Known primary central nervous system (CNS) tumors or brain metastases

- History of bleeding diathesis

- Myocardial infarction within 6 months of study day 1, symptomatic congestive heart
failure (New York Heart Association > class II), unstable angina, or unstable cardiac
arrhythmia requiring medication, or uncontrolled hypertension in the opinion of the
investigator

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

- A baseline ECG QTcF > 470 msec

- Known positive test for human immunodeficiency virus (HIV)

- Known acute or chronic hepatitis B or hepatitis C infection as determined by
serologic tests

- Other exclusion criteria may apply