Margetuximab Expanded Access Program
Sponsor: TerSera Therapeutics LLC
ClinicalTrials ID:NCT03133988
TerSera Therapeutics offers an Expanded Access Program for margetuximab, an anti-HER2 monoclonal antibody, to patients with pretreated HER2+ breast cancer. Requests are evaluated individually by treating physicians for patients ineligible for clinical studies. Physicians should consider approved therapies and ongoing trials before seeking access.
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Program Overview
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.
Description
TerSera Therapeutics LLC (TerSera) 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 TerSera to supply margetuximab for single patient use.
Eligibility Criteria
Inclusion Criteria
- TerSera 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.
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