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Approved for marketingNCT03133988Updated Feb 14, 2025

Margetuximab Expanded Access Program

An expanded access record providing Margetuximab in HER2-positive Breast Cancer and HER2-positive Carcinoma, sponsored by TerSera Therapeutics LLC. Approved for marketing. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by TerSera Therapeutics LLC · Expanded access

Study type
Expanded access
Access type
Individual patients
01

Study 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.

Read the 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.

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Conditions studied

  • HER2-positive Breast Cancer
  • HER2-positive Carcinoma
03

In context

Lead sponsor

TerSera Therapeutics LLC is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
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

Exclusion Criteria:

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Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • BiologicalMargetuximab

    anti-HER2 monoclonal antibody

    Also known as: MGAH22

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Where to request access

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03133988
Lead sponsor
TerSera Therapeutics LLC
Responsible party
Sponsor
First posted
Apr 28, 2017
Last update
Feb 14, 2025
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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