Clinical Trials

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/15/2024. Questions regarding updates should be directed to the study team contact.