Margetuximab Expanded Access Program

N/AApproved For MarketingNCT03133988

TerSera Therapeutics LLC

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.

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.

Study Type

EXPANDED_ACCESS

Conditions

HER2-positive Breast Cancer HER2-positive Carcinoma

Interventions

MargetuximabBIOLOGICAL

anti-HER2 monoclonal antibody

Eligibility

Medical Language ↔ Plain English

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:

Data from ClinicalTrials.gov

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