Trials / Approved For Marketing
Approved For MarketingNCT03133988
Margetuximab Expanded Access Program
An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- TerSera Therapeutics LLC · Industry
- Sex
- —
- Age
- —
- Healthy volunteers
- Not accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Margetuximab | anti-HER2 monoclonal antibody |
Timeline
- First posted
- 2017-04-28
- Last updated
- 2025-02-14
Source: ClinicalTrials.gov record NCT03133988. Inclusion in this directory is not an endorsement.