Margetuximab Expanded Access Program

TerSera Therapeutics

Status

Conditions: HER2-positive Breast Cancer; HER2-positive Carcinoma

Treatments: Biological: Margetuximab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03133988

MGAH22-EA

Details and patient eligibility

About

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.

Full 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.

Sex

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Exclusion Criteria: