Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Neurofibromatosis Type 2

In brief

This is a two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas.

Key facts

Study ID

NCT05130866

Run by

Recursion Pharmaceuticals Inc.

People needed

25

Starts

2022-06-20

Expected to finish

2025-08-18

Last updated by the study team

2025-10-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥12 years of age and weighing at least 40 kg
• Progressive meningioma that is amenable to volumetric analysis
• Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant)
• Adequate bone marrow function
• Has provided written informed consent/assent to participate in the study

You may not qualify if…

• Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.
• Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 12 months prior to screening.
• Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.
• History of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence.
• Received another investigational drug within 30 days prior to screening
• Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dosing cycle.

Where it is running

• House Institute — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Children's National Hospital — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Sarah Cannon Cancer Institute - HCA Midwest — Overland Park, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Minnesota / Masonic Cancer Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia University — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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