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

NCT05130866 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: REC-2282-201
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Neurofibromatosis Type 2

Keywords

Neurofibromatosis Type 2; Neurofibromatosis Type II

Outcome Measures

Primary Outcomes (2)

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

  In Cohort A, PFS is defined as the number of participants who are alive and progression-free at 6 months with progression defined as having an increase of 20% or more in the target tumor identified.

  6 months

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

  In Cohort B, PFS is defined as the time from the date of randomization until disease progression or death from any cause, whichever occurs first.

  Up to 3 years

Secondary Outcomes (10)

• Cohort A: Change from Baseline in Target Tumor Volume at 6 Months

  6 months

• Cohort A: Number of Participants with PFS at 12 and 24 Months

  12 and 24 Months

• Cohorts A and B: Objective Response Rate (ORR)

  Up to 3 years

• Cohorts A and B: Disease Control Rate (DCR)

  Up to 3 years

• Cohorts A and B: Time to Response (TTR)

  Up to 3 years

Study Arms (5)

Cohort A Adults, REC-2282 40 mg

EXPERIMENTAL

Adult participants will receive REC-2282.

Drug: REC-2282

Cohort A Adults, REC-2282 60 mg

EXPERIMENTAL

Adult participants will receive REC-2282.

Drug: REC-2282

Cohort A Adolescents, REC-2282

EXPERIMENTAL

Adolescent participants will receive REC-2282.

Drug: REC-2282

Cohort B REC-2282

EXPERIMENTAL

Participants will receive REC-2282.

Drug: REC-2282

Cohort B Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Interventions

REC-2282 DRUG

Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.

Also known as: AR-42, OSU-HDAC42, NSC-D736012

Cohort A Adolescents, REC-2282; Cohort A Adults, REC-2282 40 mg; Cohort A Adults, REC-2282 60 mg; Cohort B REC-2282

Placebo DRUG

Participants will receive placebo orally 3 times per week for 3 weeks followed by 1 week off for a 4-week cycle.

Cohort B Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Recursion Pharmaceuticals Inc.: lead

Study Sites (14)

House Institute

Los Angeles, California, 90057, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Sarah Cannon Cancer Institute - HCA Midwest

Overland Park, Kansas, 66211, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Minnesota / Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 2

Interventions

HDAC-42

Condition Hierarchy (Ancestors)

Neuroma, Acoustic; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neuroma; Neoplastic Syndromes, Hereditary; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking applies to Cohort B only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Two-staged, Phase 2/3, Randomized, Multicenter Efficacy and Safety Study.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 23, 2021
• Study Start: June 20, 2022
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)