TerminatedPhase 2/3

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

Stopped: Study was terminated due to sponsor decision. This decision was not related to safety concerns with REC-2282.

United States25 participantsStarted 2022-06-20

Plain-language summary

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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. ≥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

Exclusion criteria

✕. 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.

What they're measuring

Cohort A: Number of Participants with Progression-free survival (PFS) at 6 Months

Timeframe: 6 months

Cohort B: Number of Participants with PFS up to 3 years

Timeframe: Up to 3 years

Trial details

NCT IDNCT05130866

SponsorRecursion Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-18

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