A Phase I Study of DHES0815A for Patients with Advanced or Metastatic HER2-Positive Breast Cancer

Full Title

A Phase I, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of DHES0815A in Patients with HER2 Positive Breast Cancer

Purpose

The purpose of this study is to find the highest dose of the investigational drug DHES0815A that can be given safely in patients with inoperable or metastatic HER2-positive breast cancer that persists despite prior treatment or cannot be treated with standard therapies. DHES0815A is an antibody designed to attach to cancer cells with the HER2 protein on their surfaces. It is linked to a chemotherapy drug, and this antibody-drug combination attacks cancer cells containing HER2. In laboratory studies, DHES0815A has slowed the growth of cancers or shrunk tumors with the HER2 protein on their cell surfaces.

DHES0815A 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 inoperable or metastatic HER2-positive breast cancer that persists despite prior treatment or cannot be treated with standard therapies.
  • At least 4 weeks must pass between the completion of prior therapies and entry into 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 about this study and to inquire about eligibility, please contact Dr. Shanu Modi at 646-888-5243 .

Protocol

18-378

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases