NCT01497821 (Clinical Trial/ AMG 172)

Study Title
AMG 172 First in Human Study in Patients With Kidney Cancer (NCT01497821)

Trial Description
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.

This trial is sponsored by Amgen. [1]

Study Data

  • Condition: Kidney Cancer
  • Interventions:
    • Drugs used in this trial
      • AMG 172
  • Phase: I
  • Enrollment: 37
  • Start: January 2012
  • Estimated Completion: January 2015
  • Last verified: March 2016

Study Schematic 

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Last Editorial review: August 25, 2017
Information based on (NIH/NCI) and other sources.