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Trial record 1 of 1 for:    NCT03133988
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Margetuximab Expanded Access Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03133988
Expanded Access Status : Approved for marketing
First Posted : April 28, 2017
Last Update Posted : December 19, 2020
Information provided by (Responsible Party):

Brief Summary:
The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.

Condition or disease Intervention/treatment
HER2-positive Breast Cancer HER2-positive Carcinoma Biological: Margetuximab

Detailed Description:
MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to margetuximab and for MacroGenics to supply margetuximab for single patient use.

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients

Resource links provided by the National Library of Medicine

Intervention Details:
  • Biological: Margetuximab
    anti-HER2 monoclonal antibody
    Other Name: MGAH22

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult

Inclusion Criteria:

  • MacroGenics may consider requests on a case-by-case basis from treating physicians for patients not otherwise eligible for margetuximab clinical studies.
  • Treating physicians should consider approved therapies for a patient's disease, as well as ongoing clinical studies, before seeking expanded access use with an investigational agent.

Exclusion Criteria:

No Contacts or Locations Provided
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Responsible Party: MacroGenics Identifier: NCT03133988    
Other Study ID Numbers: MGAH22-EA
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases