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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05130866
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Recursion Pharmaceuticals Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neurofibromatosis Type 2

Additional Details

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.

Arms & Interventions

Arms

Experimental: Cohort A Adults, Dose 40 mg

Experimental: Cohort A Adults, Dose 60 mg

Experimental: Cohort A Adolescents

Starting dose of 30 mg followed by dose escalation to 40 mg and 60 mg.

Experimental: Cohort B Active

Dose TBD

Placebo Comparator: Cohort B Placebo

Interventions

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.

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

House Institute, Los Angeles, California

Status

Recruiting

Address

House Institute

Los Angeles, California, 90057

Site Contact

Ben Heifetz

[email protected]

385-374-1724

University of California Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California Los Angeles

Los Angeles, California, 90095

Site Contact

Quan Li

[email protected]

385-374-1724

Children's National Hospital, Washington, District of Columbia

Status

Recruiting

Address

Children's National Hospital

Washington, District of Columbia, 20010

Site Contact

Elizabeth Krisanda

[email protected]

202-476-6551

University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida, 32611

Site Contact

Julie Segura

[email protected]

352-273-5550

Nicklaus Children's Hospital, Miami, Florida

Status

Recruiting

Address

Nicklaus Children's Hospital

Miami, Florida, 33155

Site Contact

Jose Rodriguez Alonso

[email protected]

385-374-1724

Overland Park, Kansas

Status

Active, not recruiting

Address

Sarah Cannon Cancer Institute - HCA Midwest

Overland Park, Kansas, 66211

Site Contact

[email protected]

385-374-1724

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Paige Watson

[email protected]

617-724-2192

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Site Contact

Stephen Duggan

[email protected]

385-374-1724

Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota / Masonic Cancer Center

Minneapolis, Minnesota, 55455

Site Contact

Allison Fullenkamp

[email protected]

612-625-6125

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Grace Botzo

[email protected]

507-266-9415

Columbia University, New York, New York

Status

Recruiting

Address

Columbia University

New York, New York, 10032

Site Contact

Krishna Kesari

[email protected]

212-304-5570

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Kerina Yang

[email protected]

385-374-1724

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Sarah Woodring

[email protected]

919-684-2527

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Dreaux Abe

[email protected]

214-456-6439

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