Phase 1/2 Study Evaluating the Safety, PK/PD, and Clinical Activity of Oral JBI-778 in Patients With Brain Metastases, Leptomeningeal Disease, or Recurrent High Grade Glioma

This is a Phase 1/2, multicenter, open-label, dose-escalation and dose-expansion study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), cerebrospinal fluid penetration, and preliminary antitumor activity of orally administered JBI-778, a selective PRMT5 inhibitor, in patients with brain metastases, leptomeningeal disease, or recurrent high-grade glioma. The study consists of a dose-escalation phase to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), followed by expansion cohorts to evaluate preliminary efficacy at the RP2D.

NCT Number	NCT07751744
Lead Sponsor	Jubilant Therapeutics Inc.
Conditions	Brain Metastases From Solid Tumors, Leptomeningeal Disease, High Grade Glioma (HGG), Glioblastoma (GBM)
Enrollment	113 participants
Start Date	2028-04-01
Primary Completion	2030-03-31 (estimated)
Study Completion	2030-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-07