AMG 176 First in Human Trial in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Official Title

A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Summary:

At least one dose level of AMG 176 will achieve acceptable safety and tolerability in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia

Trial Description

Primary Outcome:

  • Incidence of adverse events and significant laboratory abnormalities
  • Evaluate PK on different cohorts
  • Determine the maximum tolerated dose (MTD)
  • Determine the maximum tolerated combination (MTC)
Secondary Outcome:
  • Demonstrate investigational product inactivation of MCL-1
  • Evaluate preliminary efficacy according to the International Myeloma Working Group uniform response criteria
This is a Phase 1, first-in-human, multicentre; non-randomized, open-label and dose-exploration study of AMG 176 administered IV in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia The study will be conducted in four parts.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society