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A Single Arm, Open-Label, Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients With Relapsed or Refractory Advanced Breast Cancer Whose Tumors Express HER2 at the 2+ Level by Immunohistochemistry and Lack Evidence of HER2 Gene Amplification by FISH

Trial Profile

A Single Arm, Open-Label, Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients With Relapsed or Refractory Advanced Breast Cancer Whose Tumors Express HER2 at the 2+ Level by Immunohistochemistry and Lack Evidence of HER2 Gene Amplification by FISH

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Feb 2022

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At a glance

  • Drugs Margetuximab (Primary)
  • Indications Advanced breast cancer
  • Focus Biomarker; Therapeutic Use
  • Sponsors MacroGenics
  • Most Recent Events

    • 11 Dec 2020 Results of a pooled analysis of margetuximab safety across 3 clinical trials (NCT01148849, NCT01828021 and NCT02492711), published in the MacroGenics Media Release
    • 25 Jul 2017 Status changed from recruiting to completed.
    • 14 Mar 2016 Planned End Date changed from 1 Dec 2015 to 1 Dec 2016 as reported by ClinicalTrials.gov record.
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