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

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.

Individual Patients
HER2-positive Breast Cancer
HER2-positive Carcinoma

Biological: Margetuximab
anti-HER2 monoclonal antibody
Other Name: MGAH22

Eligibility Criteria

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:

Eligibility Gender

Jan Baughman, MPH
(650) 624-2776

Emily Ashley
(240) 552-8073

NCT Number
MeSH Terms
Breast Neoplasms