NCT05130866

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Recursion Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cohort A (Phase 2) 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, Phase 3). 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.

Conditions

• Neurofibromatosis Type 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-20
• Primary completion: 2025-08-18
• Completion: 2025-08-18
• First posted: 2021-11-23
• Last updated: 2025-10-07

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study