Study on the Effectiveness and Safety of REC-2282 for Patients with Progressive NF2 Mutated Meningiomas

Sponsor: Recursion Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05130866

Provider View

This clinical trial is testing a new drug, REC-2282, to see if it is safe and effective for treating meningiomas (a type of brain tumor) in patients with a specific genetic mutation called NF2. The study is divided into two parts and involves multiple centers.

Patient Parameters

Program Overview

The study aims to evaluate how well the drug REC-2282 works and how safe it is for patients with meningiomas that have a mutation in the NF2 gene. It includes two parts: the first part (Cohort A) will gather early information on the drug's effects and help decide the best dose for the second part (Cohort B). In Cohort B, the drug will be compared to a placebo to see if it helps more than no treatment. Participants will go through a screening period, receive treatment, and have follow-up visits to monitor their health. Some participants will also take part in a sub-study to see how food affects the drug. After the study, there may be an option to continue receiving the drug in an open-label extension period.

Description

This study is designed to test the drug REC-2282 in patients with meningiomas that have a mutation in the NF2 gene. It is divided into two parts: Cohort A and Cohort B.

In Cohort A, adult participants will be randomly assigned to receive one of two doses of REC-2282. This part will help determine the best dose for the next phase of the study.

In Cohort B, participants will be randomly assigned to receive either the determined dose of REC-2282 or a placebo, with twice as many participants receiving the drug as those receiving the placebo.

The study includes a screening period of up to 8 weeks, a treatment period, a 4-week follow-up after treatment, and a 6-month follow-up after the study ends. The first 8 participants in Cohort A will also participate in a sub-study to see how food affects the drug. After the study, participants may have the option to continue receiving the drug in an open-label extension period.

Eligibility Criteria

Inclusion Criteria

  • Aged 12 years or older and weighing at least 40 kg (about 88 pounds).
  • Have a meningioma that is growing and can be measured.
  • Have either a sporadic meningioma with an NF2 mutation, a confirmed diagnosis of NF2 disease, or at least one NF2-related tumor.
  • Have healthy bone marrow function.
  • Have agreed to participate by signing a consent form.

Exclusion Criteria

  • Have a tumor that is causing serious symptoms and may need surgery or radiation soon.
  • Have had surgery or certain treatments on the tumor within 6 months before the study.
  • Have taken another anti-tumor medication for meningioma recently.
  • Have had another active cancer in the past 3 years, except for certain localized cancers.
  • Have taken another experimental drug within 30 days before the study.
  • Are pregnant, breastfeeding, or planning to become pregnant or father a child during the study or shortly after.

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