A Phase I/II Study of Zotatifin in People with Advanced Breast Cancer and Non-Small Cell Lung Cancer

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Full Title

A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous Zotatifin (eFT226) in Subjects with Selected Advanced Solid Tumor Malignancies

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug zotatifin in patients with advanced breast cancer or non-small cell lung cancer (NSCLC). Zotatifin is designed to block a gene eIF4A. When this gene is blocked, the genes that cause cancer cells to grow and divide are not able to function.

Some patients with breast cancer will receive zotatifin in combination with trastuzumab or fulvestrant (standard breast cancer medications). Patients with NSCLC will receive zotatifin alone. Zotatifin 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 KRAS-mutated stage IIIB or IV NSCLC that continues to grow despite platinum-based chemotherapy and immunotherapy, OR recurrent or metastatic breast cancer that persists despite prior treatment.
  • Patients should recover from the serious side effects of previous therapies before receiving 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. Ezra Rosen at 646-888-6955.

Protocol

21-323

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators