A Phase 1 Study of Avutometinib, a Dual Inhibitor of MEK and RAF, for Children and Young Adults With Advanced Solid Tumors

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Full Title

A Multi-Center Phase I Dose Escalation Study of Avutometinib (VS-6766), a RAF/MEK Clamp, in Pediatric Patients with Refractory or Recurrent Solid Tumors Harboring Activating MAPK Pathway Alterations

Purpose

Researchers want to find the best dose of avutometinib to treat children and young adults with advanced solid tumors. The people in this study have cancers that have spread or come back after treatment. In addition, their cancers have a mutation (change or variant) in a protein family called MAPK. These proteins tell cancer cells to grow.

Avutometinib slows cancer cell growth by blocking MAPK signals. It is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You or your child must:

  • Have advanced brain cancer, sarcoma, neuroblastoma, histiocytosis, or other solid tumor that keeps growing even after treatment.
  • Have cancer with MAPK mutations.
  • Have recovered from the serious side effects of previous treatments.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 3 to 30.

Contact

For more information about this study or to see if you or your child can join, please call 833-MSK-KIDS.

Protocol

23-129

Phase

Phase I (phase 1)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06104488