Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of Oral PRT811 in Subjects with Advanced Solid Tumors, CNS Lymphoma, and Recurrent High-Grade Gliomas– PRT811-01 (NCT04089449)
PRT811 is designed to be an oral, potent, and selective brain penetrant Protein Arginine Methyl Transferase 5 (PRMT5) inhibitor. PRMT5 is believed to mediate cancer progression in tumors, including central nervous system (CNS) lymphomas and glioblastoma multiforme (GBM).
This Phase 1 dose-escalation/dose-expansion study will seek to define a safe dose and schedule to be used in subsequent development of PRT811. The study will enroll patients with certain advanced solid tumors who have exhausted available treatment options, including:
- Glioblastoma multiforme (GBM)
- Primary central nervous system lymphomas (PCNSL)
- Homologous recombination deficient positive (HRD+) tumors with brain metastases