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NCT05130866 | RECRUITING | Neurofibromatosis Type 2

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

Recursion Pharmaceuticals Inc.

Brief Summary:

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 or disease

Neurofibromatosis Type 2

Intervention/treatment

REC-2282

Placebo

Phase

PHASE2

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 92 participants
Masking : DOUBLE
Masking Description : Masking applies to Cohort B only.
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2022-06-20
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas

Location Details

NCT05130866

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

House Institute

Los Angeles, California, United States, 90057

RECRUITING

United States, California

University of California Los Angeles

Los Angeles, California, United States, 90095

RECRUITING

United States, District of Columbia

Children's National Hospital

Washington, District of Columbia, United States, 20010

RECRUITING

United States, Florida

University of Florida

Gainesville, Florida, United States, 32611

RECRUITING

United States, Florida

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

ACTIVE NOT RECRUITING

United States, Kansas

Sarah Cannon Cancer Institute - HCA Midwest

Overland Park, Kansas, United States, 66211

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Minnesota

University of Minnesota / Masonic Cancer Center

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

RECRUITING

United States, New York

Columbia University

New York, New York, United States, 10032

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

RECRUITING

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 75390