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

Phase 2

Recruiting

• Conditions: Neurofibromatosis Type 2
• Interventions: Drug: Placebo; Drug: REC-2282

• Registration Number: NCT05130866
• Lead 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.

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 Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-11-23
• Study Start: 2022-06-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2027-01
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B Placebo	Placebo	-
Cohort A Adults, Dose 40 mg	REC-2282	-
Cohort B Active	REC-2282	Dose TBD
Cohort A Adults, Dose 60 mg	REC-2282	-
Cohort A Adolescents	REC-2282	Starting dose of 30 mg followed by dose escalation to 40 mg and 60 mg.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) in Cohort A	6 months	The proportion of participants in Cohort A who are alive and progression-free after 6 cycles of treatment
Progression-free survival (PFS) in Cohort B	Time from the date of randomization until disease progression or death from any cause, whichever occurs first, assessed up to 24 months.	In Cohort B, the time from the date of randomization until disease progression or death from any cause, whichever occurs first.

Trial Locations

Locations (14)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Nicklaus Children's Hospital; 🇺🇸 Miami, Florida, United States

House Institute; 🇺🇸 Los Angeles, California, United States

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Sarah Cannon Cancer Institute - HCA Midwest; 🇺🇸 Overland Park, Kansas, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Columbia University; 🇺🇸 New York, New York, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Minnesota / Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States