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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

NCT07751744 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2026-08-07

No results posted yet for this study

Summary

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.

Conditions

  • Brain Metastases From Solid Tumors
  • Leptomeningeal Disease
  • High Grade Glioma (HGG)
  • Glioblastoma (GBM)

Interventions

DRUG

JBI-778

Drug: JBI-778 Oral capsule Strengths: 20 mg, 100 mg, 250 mg Starting dose: 40 mg daily Continuous once-daily administration in 21-day cycles

Sponsors & Collaborators

  • Jubilant Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-04-01
Primary Completion
2030-03-31
Completion
2030-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751744 on ClinicalTrials.gov