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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
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03133988
Enrollment
Unknown
Registered
2017-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive Breast Cancer, HER2-positive Carcinoma

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.

Interventions

BIOLOGICALMargetuximab

anti-HER2 monoclonal antibody

Sponsors

TerSera Therapeutics LLC
Lead SponsorINDUSTRY

Eligibility

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026