A Phase 2 Study of FORE8394 in People Who Have Cancer With BRAF Mutations

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Full Title

A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants with Cancer Harboring BRAF Alterations

Purpose

Researchers are seeing how well the drug FORE8394 works in people with advanced solid tumors, including brain tumors. The people in this study include adults and children with cancers that keep growing or came back even with treatment. Their tumors have mutations (changes or variants) in the BRAF gene.

If you join this study, you will take FORE8394 with another drug called cobicistat. FORE8394 blocks the activity of BRAF proteins. Cobicistat increases the amount of FORE8394 in the body, which may help slow or stop cancer growth. Both drugs are taken orally (by mouth).

Who Can Join

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

  • Have a solid tumor that has metastasized (spread). Or you must have a central nervous system tumor (brain or spinal cord cancer) that came back after treatment.
  • Have recovered from the serious side effects of prior therapies.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 10 years or older.

Contact

For more information or to see if you can join this study, please call Dr. Eric Sherman’s office at 646-608-3776. If you are interested in this study for your child, please call 833-MSK-KIDS.

Protocol

23-137

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05503797