An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients

TerSera Therapeutics LLC0 sitesApril 28, 2017

DrugsMargetuximab

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: TerSera Therapeutics LLC
Status: Approved For Marketing
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

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.

Registry

clinicaltrials.gov

Start Date

April 28, 2017

End Date

TBD

Last Updated

last year

Study Type

Expanded Access

Investigators

Sponsor

TerSera Therapeutics LLC

Responsible Party

Sponsor

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.