AMG 172 First in Human Study in Patients With Kidney Cancer

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:

Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
Platelet count ≥ 100 x 10^9/L;
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:

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