Margetuximab Expanded Access Program

February 12, 2025 updated by: TerSera Therapeutics LLC

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

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TerSera Therapeutics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGAH22-EA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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