Margetuximab Expanded Access Program

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

• Registration Number: NCT03133988
• Lead Sponsor: TerSera Therapeutics LLC

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 Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: Not specified
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified