Back to resultsMargetuximab Expanded Access Program
Primary Purpose
HER2-positive Breast Cancer, HER2-positive Carcinoma
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Margetuximab
Sponsored by
About this trial
This is an expanded access trial for HER2-positive Breast Cancer
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:
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03133988
Brief Title
Margetuximab Expanded Access Program
Official Title
An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer, HER2-positive Carcinoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Margetuximab
Other Intervention Name(s)
MGAH22
Intervention Description
anti-HER2 monoclonal antibody
10. Eligibility
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:
12. IPD Sharing Statement
Learn more about this trial
Margetuximab Expanded Access Program
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