[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650738":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":30,"locations":29,"responsibleParty":36,"collaborators":29,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":29,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":29,"enrollmentInfo":47,"targetDuration":29,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":65,"whyStopped":29,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":29},{"fullName":5,"class":6},"Jubilant Therapeutics Inc.","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - Dose-Escalation Phase","EXPERIMENTAL","Intervention Drug: JBI-778\n\nOral capsule Strengths: 20 mg, 100 mg, 250 mg Starting dose: 40 mg daily Continuous once-daily administration in 21-day cycles",[13],"Drug: JBI-778",{"label":15,"type":10,"description":11,"interventionNames":16},"Arm 2 - High-Grade Glioma Expansion Cohort",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Arm 3 - Brain Metastases Expansion Cohort",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Arm 4 - Leptomeningeal Disease Expansion Cohort",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","JBI-778","Drug: JBI-778\n\nOral capsule Strengths: 20 mg, 100 mg, 250 mg Starting dose: 40 mg daily Continuous once-daily administration in 21-day cycles",[9,15,18,21],null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Melda Dolan, MD","CONTACT","3144989959","Melda.Dolan@jubl.com",{"type":37,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100650738","phase-1-phase-12-study-evaluating-the-safety-pkpd-and-clinical-activity-of-oral-jbi-778-in-patients-with-brain-metastases-leptomeningeal-disease-or-recurrent-high-grade-glioma-100650738",false,"NCT07751744","Phase 1\u002F2 Study Evaluating the Safety, PK\u002FPD, and Clinical Activity of Oral JBI-778 in Patients With Brain Metastases, Leptomeningeal Disease, or Recurrent High Grade Glioma","A Phase 1\u002F2, Multicenter, Open-Label, Dose-Escalation\u002FExpansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered JBI-778 in Patients With Brain Metastasis, Leptomeningeal Disease, or High Grade Recurrent Glioma","Inclusion Criteria:\n\nMale or female patients aged ≥18 years.\n\nHistologically or cytologically confirmed:\n\nSolid tumors with stable brain metastases (Dose Escalation Part), or Recurrent\u002Fprogressive high-grade glioma, or Brain metastases from NSCLC, breast cancer, or melanoma, or Leptomeningeal disease (Dose Expansion Part).\n\nAdequate organ function:\n\nANC ≥1,500\u002Fmm³ Platelets ≥100,000\u002Fmm³ Hemoglobin \\>8.0 g\u002FdL Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert syndrome) AST\u002FALT ≤2.5 × ULN (≤5 × ULN if liver metastases present) Creatinine clearance ≥60 mL\u002Fmin PT\u002FaPTT ≤1.5 × ULN (or stable anticoagulation therapy) At least one measurable lesion on MRI according to applicable RANO criteria, or positive CSF cytology for leptomeningeal disease.\n\nResolution of clinically significant toxicities from prior therapy to Grade ≤1 (except alopecia, Grade 2 peripheral neuropathy, or chronic Grade 2 endocrinopathies due to prior immunotherapy).\n\nECOG performance status ≤2. Ability to swallow oral medication. Life expectancy ≥3 months. Willing and able to provide written informed consent. Willingness to use effective contraception during treatment and for 3 months after the last dose.\n\nAdditional Dose Escalation Cohort Inclusion Criteria:\n\nHistologically or cytologically confirmed solid tumors with stable treated brain metastases and no available effective treatment options.\n\nNeurologically stable brain metastases without progression or hemorrhage for ≥4 weeks following treatment.\n\nOff systemic corticosteroids for symptomatic brain metastases for ≥14 days before enrollment.\n\nAdditional Dose Expansion Cohort Inclusion Criteria:\n\nRecurrent or progressive high-grade glioma after standard therapy including radiation and temozolomide.\n\nBrain metastases from melanoma, NSCLC, or breast cancer meeting protocol-defined prior treatment requirements.\n\nLeptomeningeal disease with protocol-defined prior therapy requirements.\n\nExclusion Criteria:\n\nSystemic anticancer therapy or investigational therapy within 2 weeks or 5 half-lives before first dose.\n\nMajor surgery within 21 days before first dose or not recovered from surgery. Conditions that may significantly impair drug absorption. Radiotherapy within 2 weeks prior to study treatment (except permitted palliative radiation or stereotactic radiosurgery).\n\nSevere or unstable medical conditions including:\n\nNYHA Class III\u002FIV heart failure Uncontrolled hypertension Uncontrolled diabetes Significant psychiatric illness Uncontrolled arrhythmias Myocardial infarction within 6 months Congenital long QT syndrome or QTcF \\>470 msec. History of optic neuritis or optic neuropathy. Other active malignancy likely to interfere with study assessments. Live vaccine within 30 days before first dose. Known active HIV infection or active hepatitis B or C infection (HCV RNA-negative patients may be eligible).\n\nUse of strong or moderate CYP3A inhibitors within 14 days or 5 half-lives before Cycle 1 Day 1, or grapefruit-containing products within 7 days.\n\nActive gastrointestinal disease or malabsorption syndrome affecting drug absorption.\n\nAcute illness within 14 days before first dose unless approved by investigator and sponsor.\n\nActive infection requiring systemic antimicrobial or antiviral therapy not completed before treatment.\n\nPregnant or breastfeeding women. Concurrent participation in another investigational drug study. Previous treatment with JBI-778 in this study. Any condition that, in the investigator's opinion, places the patient at unacceptable risk or prevents compliance with study requirements.\n\nFor Dose Escalation Part only: ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of brain metastases (except protocol-permitted low-dose corticosteroids).","ALL","18 Years",{"count":48,"type":49},113,"ESTIMATED","INTERVENTIONAL",[52,53],"PHASE1","PHASE2","This is a Phase 1\u002F2, 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.",[56,57,58,59],"Brain Metastases From Solid Tumors","Leptomeningeal Disease","High Grade Glioma (HGG)","Glioblastoma (GBM)",[26,61,62,57,63,64],"PRMT5 Inhibitor","Brain Metastases","High-Grade Glioma","Glioblastoma","NOT_YET_RECRUITING","2026-08-03",{"date":68,"type":69},"2026-08-07","ACTUAL",{"date":71,"type":49},"2028-04-01",{"date":73,"type":49},"2030-03-31",{"name":5,"class":6}]