Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas
Reason given: Study was terminated due to sponsor decision. This decision was not related to safety concerns with REC-2282.
Key facts
- Where
- Boston, Dallas, Durham, Gainesville, Los Angeles, Miami, Minneapolis, New York, Overland Park, Rochester, and Washington D.C., United StatesSee the 14 sites
- Phase
- Phase 2/3
Where in United States
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- UT Southwestern Medical CenterDallas, United StatesNo longer taking part
- Duke University Medical CenterDurham, United StatesNo longer taking part
- University of FloridaGainesville, United StatesNo longer taking part
- House InstituteLos Angeles, United StatesNo longer taking part
- University of California, Los AngelesLos Angeles, United StatesNo longer taking part
- Nicklaus Children's HospitalMiami, United StatesNo longer taking part
- University of Minnesota/Masonic Cancer CenterMinneapolis, United StatesNo longer taking part
- Columbia UniversityNew York, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- Sarah Cannon Cancer Institute - HCA MidwestOverland Park, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- Children's National HospitalWashington D.C., United StatesNo longer taking part
Trial details
- Who runs it
- Recursion Pharmaceuticals Inc.
- Trial code
- NCT05130866
- Record updated
- 17 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: ≥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: 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; Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months; 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.