A Phase I/II Study of U3-1402 for Patients with HER3-Positive Metastatic Breast Cancer

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Full Title

Phase 1/2, Multicenter, Open-Label, Multiple Dose, First-in-Human Study of U3-1402 in Subjects With Her3-Positive Metastatic Breast Cancer

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug U3-1402 in patients with metastatic breast cancer that contains the HER3 protein. U3-1402 is an antibody that attaches to HER3. U3-1402 is also connected to a chemotherapy drug.

Researchers think that U3-1402 could slow tumor growth by attaching to the HER3 protein on breast cancer cells, delivering the chemotherapy drug directly into the cells and destroying them. U3-1402 is given intravenously (by vein).

Eligibility

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

  • Patients must have HER3-positive, HER2-negative metastatic breast cancer that cannot be successfully treated with other therapies.
  • At least 3 weeks must pass between the completion of prior treatments and entry into the study (2 weeks since completion of hormonal therapy).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-4558.

Protocol

19-282

Phase

I/II

Investigator

Co-Investigators

Diseases