A Phase I Study of BTRC4017A Immunotherapy for Patients with Advanced or Metastatic HER2-Expressing Breast Cancer

Full Title

Phase IA/B, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination with Trastuzumab in Patients with Locally Advanced or Metastatic HER2-expressing Cancers

Purpose

The purpose of this study is to find the highest dose of the investigational drug BTRC4017A that can be given safely in patients with advanced or metastatic HER2-positive breast cancer. BTRC4017A is an antibody that attaches to two targets: cancer cells with HER2 on the surface and immune cells called T cells. BTRC4017A is an immunotherapy designed to activate T cells to kill HER2-containing cancer cells. It is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have an inoperable or metastatic HER2-positive breast cancer that cannot be successfully treated with another therapy and/or has continued to grow despite prior treatment.
• The cancer must have continued to grow during or after the most recent treatment for inoperable or metastatic breast cancer.
• At least 4 weeks must pass since the completion of previous treatment and entry into the study. For patients who have had prior HER2-targeting therapies, a sufficient amount of time must pass to allow for the drug to be cleared from the body (more than 140 days for trastuzumab and more than 65 days for ado-trastuzumab).
• Patients may not have received systemic immunotherapies within 12 weeks of entering the study.
• Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
• This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Shanu Modi at 646-888-5243.