A Phase II Study of Milademetan in People with Advanced Solid Tumors

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Full Title

A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug milademetan (also known as RAIN-32) in people with advanced solid tumors that have continued to grow despite standard treatment or for which no standard therapy exists. The patients in this study will have a cancer that makes extra copies of a gene called MDM2.  

Milademetan blocks the MDM2 protein, which is found in excess in cancer cells that have extra copies of the MDM2 gene. This blocking action may stop cancer cells from growing and dividing. Milademetan is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have an advanced solid tumor that cannot be successfully treated with standard therapies and makes extra copies of the MDM2 gene.
  • Patients should recover from the serious side effects of prior therapies before receiving milademetan.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact 646-497-9067.

Protocol

21-511

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases