Abemaciclib in Newly Diagnosed Meningioma Patients

Inclusion Criteria:

• Participant with an intracranial WHO Grade 3 meningioma or lower grade meningiomathat has progressed to WHO grade 3 that have received prior radiation therapy.

• Resected tissue must demonstrate: (a) RB positivity on immunohistochemistry (IHC);or, no RB mutations on next-generation sequencing (NGS).

• A washout period of 14 to 35 days is required between end of RT and Day 1 and mustbe fully recovered from the acute effects of RT.

• Ability to understand and the willingness to sign a written informed consentdocument (personally or by the legally authorized representative, if applicable).

• Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable).Participant must be willing and able to comply with scheduled visits, treatmentplans, laboratory tests and other procedures.

• Age ≥18 years at time of consent.

• Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.

• Ability to swallow oral medications.

• Participant has adequate bone marrow and organ function

• Confirmed negative serum pregnancy test (β-hCG) before starting study treatment orparticipant who is no longer of childbearing potential due to surgical, chemical, ornatural menopause.

• For females of reproductive potential: use of highly effective contraception duringstudy participation and for an additional 3 weeks after the end of treatmentadministration.

• For males of reproductive potential: use of condoms or other methods to ensureeffective contraception with partner and for an additional 3 weeks after the end oftreatment administration.

Exclusion Criteria:

• Prior history of cancer with ongoing treatment of disease.

• Current use of coumarin-derived anticoagulant for treatment, prophylaxis orotherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinuxis allowed.

• Pregnancy, breastfeeding or lactation.

• Known allergic reactions to components of the abemaciclib.

• Active infection or fever >38.5°C requiring systemic antibiotic, antifungal orantiviral therapy within 4 weeks of Day 1.

• Known to have active (acute or chronic) or uncontrolled severe infection, liverdisease such as cirrhosis, decompensated liver disease, and active and chronichepatitis.

• Known active systemic bacterial infection, fungal infection, or detectable viralinfection .

• Participant has serious and/or uncontrolled preexisting medical condition(s) that,in the judgment of the investigator, would preclude participation in this study.

• Prior therapy with any CDK4/6 inhibitor.

• Treatment with another investigational drug within 5 half-lives of theinvestigational product.

• The patient has a personal history of any of the following conditions: syncope ofcardiovascular etiology, ventricular arrhythmia of pathological origin (including,but not limited to, ventricular tachycardia and ventricular fibrillation), or suddencardiac arrest.