An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients
| Registry | NCT03133988 |
|---|---|
| Status | Approved for marketing |
| Study type | Expanded access |
| Sponsor | TerSera Therapeutics LLC (Industry) |
| Conditions | HER2-positive Breast Cancer, HER2-positive Carcinoma |
| Interventions | Margetuximab (Biological) |
| Dates | first posted 2017-04-28, last updated 2025-02-14 |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for HER2-positive Breast Cancer All trials for HER2-positive Carcinoma All trials of Margetuximab
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.
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.
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. Exclusion Criteria: