A Phase IB/IIA Study of Mirdametinib on Its Own or in Combination with Fulvestrant in People with Advanced Breast Cancer and Other Solid Tumors with Certain Genetic Changes

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Full Title

A Phase 1b / 2a, Open-label Platform Study to Evaluate Mirdametinib as Monotherapy or in Combination with Other Anticancer Agents in Patients with Advanced Solid Cancers Harboring MAPK-activating Mutations

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the investigational drug mirdametinib in people with solid tumors containing certain genetic changes (mutations). It will be assessed in combination with the drug fulvestrant in women with estrogen receptor-positive HER2-negative breast cancer containing changes in a molecular pathway called MAPK, and on its own in men and women with advanced solid tumors that contain mutations in the MEK1 or MEK2 genes.

Mirdametinib is designed to block the proteins MEK1 and MEK2. MEK1 and MEK2 play an important role in the MAPK pathway, which controls cancer cell growth and survival. When these proteins are blocked, the proteins that cause cancer cells to grow and divide are not able to function. By blocking MEK1 and MEK2, mirdametinib may slow or stop the growth of cancer. Mirdametinib is taken orally (by mouth).

Fulvestrant works to prevent breast cancer growth by blocking the estrogen receptor protein on cancer cells. It is given as an injection.

Eligibility

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

  • Participants must be women with estrogen receptor-positive HER2-negative breast cancer containing NF1 or MAPK gene mutations, or people with other advanced solid tumors that contain mutations in the MEK1 or MEK2 genes.
  • The serious side effects of prior therapies should resolve before receiving the study treatment.
  • 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, they must be well enough that they would be able to carry out office work or light housework.
  • This study is for people 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

21-288

Phase

I/II

Investigator

Co-Investigators

Diseases