Purpose

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

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. ≥12 years of age and weighing at least 40 kg 2. Progressive meningioma that is amenable to volumetric analysis 3. 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) 4. Adequate bone marrow function 5. Has provided written informed consent/assent to participate in the study

Exclusion Criteria

  1. Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months. 2. Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening. 3. Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening. 4. 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. 5. Received another investigational drug within 30 days prior to screening 6. Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dose of IMP.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A Two-staged, Phase 2/3, Randomized, Multicenter Efficacy and Safety Study.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Masking applies to Cohort B only.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A Adults, Dose 40 mg
  • Drug: REC-2282
    Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.
    Other names:
    • AR-42
    • OSU-HDAC42
    • NSC-D736012
Experimental
Cohort A Adults, Dose 60 mg
  • Drug: REC-2282
    Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.
    Other names:
    • AR-42
    • OSU-HDAC42
    • NSC-D736012
Experimental
Cohort A Adolescents
Starting dose of 30 mg followed by dose escalation to 40 mg and 60 mg.
  • Drug: REC-2282
    Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.
    Other names:
    • AR-42
    • OSU-HDAC42
    • NSC-D736012
Experimental
Cohort B Active
Dose TBD
  • Drug: REC-2282
    Participants will receive REC-2282 3 times per week orally for 3 weeks followed by 1 week off for a 4-week cycle.
    Other names:
    • AR-42
    • OSU-HDAC42
    • NSC-D736012
Placebo Comparator
Cohort B Placebo
  • Drug: Placebo
    Participants will receive placebo orally 3 times per week for 3 weeks followed by 1 week off for a 4-week cycle.

Recruiting Locations

Children's National and nearby locations

Children's National Hospital
Washington, District of Columbia 20010
Contact:
Elizabeth Krisanda
202-476-6551
ekrisanda@childrensnational.org

More Details

NCT ID
NCT05130866
Status
Recruiting
Sponsor
Recursion Pharmaceuticals Inc.

Study Contact

Recursion Pharmaceuticals
385-374-1724
clinicaltrials@recursionpharma.com

Detailed Description

This is a two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas, with either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations. Cohort A will provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the dose in the confirmatory part of the study (Cohort B). The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas. In both cohorts, there will be a screening period of up to 8 weeks, a treatment period, a 4-week safety follow-up period after the end of treatment, and a 6-month post-study follow-up. The first 8 participants enrolled in Cohort A will complete a food effect run-in sub study. At the end of the study period, participants may be offered participation in an open-label extension (OLE) period. In Cohort A, adult participants will be randomized to one of two dose levels of REC-2282. In Cohort B, participants will be randomized to REC-2282 treatment (dose to be determined from Cohort A) arm or placebo arm in a ratio of 2:1.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.