Megan Mantica
This phase I study will evaluate the safety and tolerability of vorasidenib in combination with lomustine and determine the recommended combination dose (RCD) of vorasidenib in adults with recurrent IDH1- or IDH2-mutant glioma. The study consists of a dose de-escalation phase followed by a dose-expansion cohort to further evaluate safety and preliminary clinical activity.
Isocitrate dehydrogenase (IDH)-mutant gliomas represent a molecularly distinct subset of diffuse gliomas and account for a substantial proportion of primary brain tumors diagnosed in young and middle-aged adults. Despite multimodality treatment approaches including surgery, radiotherapy, and chemotherapy, recurrent disease remains inevitable for most patients, and effective treatment options at recurrence are limited. Mutations in IDH1 and IDH2 result in production of the oncometabolite D-2-hydroxyglutarate, which contributes to gliomagenesis through epigenetic and metabolic dysregulation. Vo…
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment: 1. Age ≥18 years. 2. Karnofsky performance status score of ≥ 60%. 3. Be able to understand and willing to sign informed consent or assent as determined by local requirements. 4. Be willing to comply with scheduled visits, treatment plans, and laboratory tests, including serial peripheral blood sampling during the study. 5. Must have recurrent IDH-mutant oligodendroglioma or astrocytoma grade 2-4 harboring IDH1 and/or IDH2 mutation per WHO 2021 criteria. 6. Must have IDH1 (IDH1 R132H/…
Oral inhibitor of mutant IDH1 and IDH2 administered daily in combination with lomustine.
Oral alkylating nitrosourea chemotherapy that penetrates the blood-brain barrier and is used for the treatment of brain tumors.
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