Evaluating REC-2282 for treating progressive meningiomas in NF2 patients
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
This study is testing a new drug called REC-2282 to see if it can help people with progressive meningiomas caused by NF2 feel better and improve their condition.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Recursion Pharmaceuticals Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Trial ID | NCT05130866 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a two-staged, Phase 2/3, randomized, multi-center investigation assessing the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas. The study consists of two cohorts: Cohort A will gather early data on the drug's effects and help determine the appropriate dosing for Cohort B, which will compare REC-2282 to a placebo. Participants will undergo a screening period, treatment phase, and follow-up assessments to monitor safety and efficacy. The trial aims to provide insights into a potential new treatment option for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 and older with progressive meningiomas that have confirmed NF2 mutations.
Not a fit: Patients with significant clinical symptoms requiring immediate surgery or radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new therapeutic option for patients with progressive NF2 mutated meningiomas.
How similar studies have performed: While this approach is novel for NF2 mutated meningiomas, similar studies targeting other tumor types have shown promising results.
Eligibility criteria
Show full 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.
Where this trial is running
Los Angeles, California and 13 other locations
- House Institute — Los Angeles, California, United States (Recruiting)
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- Children's National Hospital — Washington, District of Columbia, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Nicklaus Children's Hospital — Miami, Florida, United States (Recruiting)
- Sarah Cannon Cancer Institute - HCA Midwest — Overland Park, Kansas, United States (Active_not_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- University of Minnesota / Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Recursion Pharmaceuticals
- Email: clinicaltrials@recursionpharma.com
- Phone: 385-374-1724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.