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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

ConditionsBrain Metastases From Solid TumorsLeptomeningeal DiseaseHigh Grade Glioma (HGG)Glioblastoma (GBM)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJubilant Therapeutics Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • JBI-778

    Drug

    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

Treatment groups

113 Participants
are divided into 4 treatment groups
Group A: Arm 1 - Dose-Escalation PhaseExperimental treatment 1 intervention
Group B: Arm 2 - High-Grade Glioma Expansion CohortExperimental treatment 1 intervention
Group C: Arm 3 - Brain Metastases Expansion CohortExperimental treatment 1 intervention
Group D: Arm 4 - Leptomeningeal Disease Expansion CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1 - Incidence of Dose Limiting Toxicities (DLTs)

Number of participants with dose-limiting toxicity (DLT) events during the DLT monitoring period. DLTs are defined per protocol criteria and graded using NCI CTCAE Version 5.0.

Time frame
At the end of Cycle 1 (each cycle is 21 days)
2

Phase 2 High-Grade Glioma Cohort: Objective Response Rate (ORR)

Investigator-assessed ORR according to Response Assessment in Neuro-Oncology (RANO) criteria.

Time frame
Up to 2 years
3

Phase 2 Brain Metastases Cohort: Objective Response Rate (ORR)

Investigator-assessed ORR according to RANO Brain Metastases (RANO-BM) criteria.

Time frame
Up to 2 years.
4

Phase 2 Leptomeningeal Disease Cohort: Overall Survival (OS)

Overall survival in participants with leptomeningeal disease.

Time frame
Up to 2 years.

Secondary outcomes

1

Incidence of Adverse Events

Incidence of treatment-emergent adverse events, serious adverse events, and adverse events graded according to NCI CTCAE Version 5.0.

Time frame
Up to 2 years
2

Maximum Plasma Concentration (Cmax) of JBI-778

Maximum observed plasma concentration of JBI-802 following dosing. Units: ng/mL

Time frame
From Cycle 1 Day 1 up to Cycle 2 Day 1 (each cycle is 21 days)
3

Area Under the Plasma Concentration-Time Curve (AUC0-t) of JBI-778

Area under the plasma concentration-time curve from time 0 to last measurable concentration.

Time frame
From Cycle 1 Day 1 up to Cycle 2 Day 1 (each cycle is 21 days)
4

Time to Maximum Plasma Concentration (Tmax) of JBI-778

Time to reach maximum plasma concentration.

Time frame
From Cycle 1 Day 1 up to Cycle 2 Day 1 (each cycle is 21 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jubilant Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: