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Clinical Trials/NCT03133988
NCT03133988Approved For MarketingNot Applicable

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

TerSera Therapeutics LLC0 sitesStarted: April 28, 2017Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Approved For Marketing
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Expanded Access

Eligibility Criteria

Accepts Healthy Volunteers
No

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

  • Not provided

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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