A Phase II/III Study of REC-2282 in People with NF2-Mutated Meningiomas

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Full Title

A Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas

Purpose

The purpose of this study is to find the highest dose of the investigational drug REC-2282 that can be given safely in people with meningiomas that contain a mutation in the neurofibromatosis type 2 (NF2) gene. REC-2282 blocks an enzyme called HDAC, which is involved in the growth of tumor cells, including NF2-mutated meningiomas. By blocking HDAC, REC-2282 may help stop these tumors from growing and also kill tumor cells. Researchers think REC-2282 could work as well as surgery and radiotherapy, the standard treatments for this type of tumor. REC-2282 is taken orally (by mouth).

Who Can Join

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

  • Participants must have NF2-mutated meningioma of at least 1 cm in size.
  • At least 3 months must pass between the completion of prior anticancer medications and 6 months since surgery or radiation therapy and receipt of REC-2282.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 12 and older.

Contact

For more information or to see if you can join this study, please call 212-610-0261. You may also call Dr. Thomas Kaley’s office at 212-639-5122.

Protocol

22-372

Phase

Phase II/III (phases 2 and 3 combined)

Disease Status

Relapsed or Refractory

Investigator

ClinicalTrials.gov ID

NCT05130866