AMG 172 First in Human Study in Patients With Kidney Cancer
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in
subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or
who have refractory disease following at least two prior therapies. The purpose of the study
is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective
response rate in patients with ccRCC receiving AMG 172. The study will be conducted in two
Parts: Part 1 will explore doses of AMG 172 given every two weeks and every three weeks to
determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated dose
(MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall response
rate in subjects treated at the MTD established in Part 1 for either every two week or every
three week dosing.