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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
House Institute
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Children's National Hospital
Cohort A: Number of Participants with Progression-free survival (PFS) at 6 Months
In Cohort A, PFS is defined as the number of participants who are alive and progression-free at 6 months with progression defined as having an increase of 20% or more in the target tumor identified.
Time frame: 6 months
Cohort B: Number of Participants with PFS up to 3 years
In Cohort B, PFS is defined as the time from the date of randomization until disease progression or death from any cause, whichever occurs first.
Time frame: Up to 3 years
Cohort A: Change from Baseline in Target Tumor Volume at 6 Months
Time frame: 6 months
Cohort A: Number of Participants with PFS at 12 and 24 Months
In Cohort A, PFS is defined as the number of participants who are alive and progression-free at 12 and 24 months with progression defined as having an increase of 20% or more in the target tumor identified.
Time frame: 12 and 24 Months
Cohorts A and B: Objective Response Rate (ORR)
Time frame: Up to 3 years
Cohorts A and B: Disease Control Rate (DCR)
Time frame: Up to 3 years
Cohorts A and B: Time to Response (TTR)
Time frame: Up to 3 years
Cohorts A and B: Duration of Response (DOR)
Time frame: Up to 3 years
Cohorts A and B: Time to Surgery/radiation for Target Tumors
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Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Sarah Cannon Cancer Institute - HCA Midwest
Overland Park, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota / Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 4 more locations
Time frame: Up to 3 years
Cohorts A and B: Maximum Observed Plasma Concentration (Cmax) of REC-2282
Time frame: Up to 3 years
Cohorts A and B: Time to Maximum Plasma Concentration (Tmax) of REC-2282
Time frame: Up to 3 years
Cohorts A and B: Area under the curve from 0 to 24hr (AUC) of REC-2282
Time frame: Predose to 24 hours postdose