A Phase I Study of BAY 2701439 in People with HER2-Expressing Cancers

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Full Title

A Phase 1 Open-Label, First-in-Human, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of Thorium-227 Labeled Antibody-Chelator Conjugate BAY 2701439, in Participants with Advanced HER2-Expressing Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug BAY 2701439 that can be given safely in patients with inoperable or metastatic breast, stomach, or gastroesophageal cancer (cancer where the esophagus meets the stomach) that has come back after prior treatment or cannot be treated with standard therapies and has a protein on its cell surfaces called HER2.

The study treatment will be given as two intravenous (through a vein) injections:

  • BAY 2701439, which contains an antibody linked to a radioactive element (radionuclide). The antibody has been designed in a laboratory to attach to cancer cells with the HER2 protein on their surfaces. The radionuclide releases radiation as it breaks down.
  • BAY 2701438, which contains only the antibody part of the study treatment.

Giving the study treatment in two injections allows for the correct dose of both the radionuclide and the antibody parts of the study drug. The dose of the antibody is important to make sure that the study treatment is able to move through the body to reach the cancer, attach to HER2 on the cancer cells, and not be eliminated from the body too quickly.

Eligibility

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

  • Patients must have HER2-producing inoperable or metastatic breast, stomach, or gastroesophageal cancer that has come back after prior treatment or cannot be treated with standard therapies.
  • At least 4 weeks must pass between the completion of prior therapies and receipt of the study treatment.
  • 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. Steven Maron 646-888-6780.

Protocol

20-282

Phase

I

Disease Status

Relapsed or Refractory

Investigator