[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-who-grade-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-who-grade-iv":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100584008","early-phase-1-clinical-trial-of-bms-986504-in-recurrent-gbm-patients-100584008",false,"NCT06883747","Clinical Trial of BMS-986504 in Recurrent GBM Patients","A Phase 0\u002F1 Study of BMS-986504, a MTA Cooperative PRMT5 Inhibitor in Recurrent Glioblastoma Participants With MTAP Deleted Tumors Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-Triggered Expansion Cohort","Inclusion Criteria:\n\n* Participants with the diagnosis of glioblastoma by the 2021 WHO criteria, who have progressed on or following previous tumor-directed therapy, which must have included a maximal safe resection (biopsy allowed if it was deemed unsafe to resect) and fractionated radiotherapy (RT).\n* Patients with archival tissue demonstrating MTAP loss\u002Fdeletion confirmed through NGS will be qualified for Phase 0 portion of the study.\n* Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.\n* Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤ 1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 21 days is required between the last chemotherapy dose and Day 1 (provided the participant did not receive RT).\n* Age ≥ 18 at time of consent\n* Have a performance status (PS) of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale\n* Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):\n\n  * Adequate Bone Marrow Function: Absolute neutrophil count ≥ 1,500\u002FmcL; Platelets (at time of surgery) ≥ 100,000\u002FmcL; Hemoglobin ≥ 9.0 g\u002FdL (participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.)\n  * Adequate Hepatic Function: Total Bilirubin ≤ 1.5 X ULN; Participants with Gilbert's syndrome with a total bilirubin ≤ 2.0 times ULN and direct bilirubin within normal limits are permitted; AST (SGOT) ≤ 3 X institutional ULN; ALT (SGPT) ≤ 3 X institutional ULN\n  * Adequate Renal Function: Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 by Chronic Disease Epidemiology Collaboration (CKD-EPI) equation; Serum creatinine ≤ 1.5 X ULN or estimated creatinine clearance \\>\u002F= 60 mL\u002Fmin (calculated using Institutional standard method)\n  * Coagulation Function: INR ≤ 1.5 X ULN\n* Ability to swallow oral medications without crushing or chewing.\n* Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.\n* For females of reproductive potential: use of highly effective contraception for at least 28 days prior to treatment and agreement to use such a method during study participation and for an additional 7 months after the end of treatment administration.\n* Females of child-bearing potential must agree not to breastfeed starting at screening, throughout the study period and for 7 months after final study drug administration.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and avoid sperm donation for the duration of the study and for an additional 4 months after the end of treatment administration.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures.\n* Participant understands the informed consent document and has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.\n\nExclusion Criteria:\n\n* Inability to undergo MRI brain with intravenous (IV) contrast\n* Known active systemic bacterial infection (IV antibiotics or fever \\> 38.5°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening of viral infection is not required for enrollment.\n* Cardiovascular abnormalities including:\n\n  * LVEF \\\u003C 50%\n  * History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \\> 480 msec, except for right bundle branch block.\n  * Uncontrolled\u002Fsymptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the following: Cardiac angioplasty or stenting, unstable angina pectoris, myocardial infarction, stroke\u002Ftransient ischemic attack, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association (NYHA) class III-IV congestive heart failure, pericarditis, atrial fibrillation or other arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).\n* Symptomatic or radiographic leptomeningeal disease.\n* Known other concurrent severe and\u002For uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., Celiac disease, Crohn's disease, gastric bypass, malabsorption, chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).\n* With the exception of alopecia, any unresolved toxicities from prior therapy greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) Grade 1 at the time of starting study treatment and patients with chronic Grade 2 unresolved toxicities may be eligible following discussion with the Principal Investigator.\n* Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product whichever is longer.\n* Prior treatment with another PRMT5 inhibitor.\n* Known allergic reactions to components of BMS-986504: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol\u002Fmacrogol, and talc.\n* Use of strong inhibitors and strong inducers of CYP3A4\u002FP-gp. Consider using alternative medications, per Investigator judgment.\n* Concurrent use of medications known to prolong the QT interval (e.g., certain antiarrhythmics, antibiotics, antipsychotics, and antidepressants) unless discontinued for an appropriate washout period as determined by the investigator.\n* Participants who have received live\u002Fattenuated vaccine within 30 days of anticipated first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is an open-label, multi-center, Phase 0\u002F1 dose-escalation trial designed to enroll up to 12 total recurrent glioblastoma (rGBM) participants with confirmed MTAP loss\u002Fdeletion in their archival or pretreatment biopsy tissue, who are scheduled for surgical resection. MTAP loss\u002Fdeletion will be determined by next-generation sequencing (NGS). The trial will include a dose escalation design to evaluate the pharmacokinetics (PK) and safety and tolerability of BMS-986504 (MRTX1719). The trial will be composed of a Phase 0 component and an Expansion Phase 1 component. Participants with tumors demonstrating a positive PK response in the Phase 0 component of the study will be eligible to enroll into the the Phase 1 component that will include 21-day cycles of therapeutic dosing of BMS-986504.",[26],"Glioblastoma WHO Grade IV",[28,29,30],"MTAP loss","MTAP deletion","MTAP del","RECRUITING","2026-06-22",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":35},"2025-04-28",{"date":39,"type":20},"2027-09-28",{"name":41,"class":42},"Nader Sanai","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100575530","phase-1-bc008-1a-injection-for-recurrent-cns-who-g4-glioma-100575530","NCT06773481","BC008-1A Injection for Recurrent CNS WHO G4 Glioma","A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of BC008-1A Injection in Subjects With Recurrent CNS WHO Grade 4 Glioma.","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form;\n2. Recurrent CNS WHO grade 4 glioma: Subjects with CNS WHO grade 4 glioma confirmed by histopathology, who have experienced disease progression as diagnosed by MRI and evaluated by RANO criteria after standard treatment and have no surgical plan;\n3. Male or female aged ≥ 18 years old;\n4. Expected survival time ≥ 12 weeks;\n5. According to the RANO criteria, there is at least one measurable intracranial tumor lesion;\n6. KPS ≥ 70;\n7. Have sufficient hematological function, liver function and renal function, and meet the following laboratory test results before enrollment (withoutusing any cell growth factors, platelet and red blood cell transfusion or other blood transfusion treatments within 1 week before the first dose of study treatment):\n\n   * Basically normal liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN (patients with known Gilbert disease with serum bilirubin level ≤3 × ULN can be included), alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN;\n   * Basically normal renal function: Creatinine (Cr) ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin;\n   * Basically normal coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for subjects receiving anticoagulant treatment, the investigator judges that INR, PT and APTT are within the safe and effective treatment range and there is no clinical condition of active bleeding or increased bleeding risk);\n   * Basically normal hematological system: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (without granulocyte colony-stimulating factor treatment), platelet (PLT) ≥ 100 × 10\\^9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL, white blood cell count ≥ 2.0 × 10\\^9\u002FL, lymphocyte count ≥ 0.5 ×10\\^9\u002FL.\n8. Female subjects of childbearing age or male subjects whose partners are women of childbearing age need to agree to take effective contraceptive measures during the trial period (from signing the ICF to 6 months after the last dose).\n\nExclusion Criteria:\n\n1. Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs;\n2. Having suffered from other malignant tumors and currently requiring treatment (except for cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin that have been adequately treated);\n3. Having an autoimmune disease or a history of autoimmune diseases or related symptoms;\n4. Subjects who cannot undergo MRI (such as those with a pacemaker implanted, non-removable metal dentures, claustrophobia, etc.);\n5. Subjects who have received chemotherapy (those who have used nitrosourea drugs within 42 days before the first receipt of the experimental drug cannot be enrolled), radiotherapy, biotherapy, endocrine therapy, targeted therapy, tumor-treating fields therapy, immunotherapy or other anti-tumor treatments such as anti-tumor Chinese patent medicines within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter), or subjects who have received any clinical study treatment and the interval from the first use of the study drug is ≤ 28 days;\n6. Subjects with tumor lesions involving the brainstem, spinal cord or leptomeningeal dissemination and metastasis;\n7. Those who have used corticosteroids within 1 month before participating in the trial and have received systemic treatment with a daily dose higher than 3 mg of dexamethasone or an equivalent dose of other hormones;\n8. The toxicity caused by previous anti-tumor treatments has not decreased to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities judged by the investigator to have no safety risks, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.);\n9. Those who have received live attenuated vaccines within 4 weeks before the first administration of the study drug or plan to receive them during the study period;\n10. Subjects with active infections at present (such as acute bacterial infections, tuberculosis, pulmonary infections, etc.);\n11. Those who are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and whose HBV DNA is higher than the upper limit of the normal value of the site, or those judged by doctors to have active hepatitis, hepatitis C virus (HCV) infection, or those who are positive for human immunodeficiency virus (HIV) antibody, or those who are positive for Treponema pallidum antibody (Tp-Ab);\n12. Those with cardiac clinical symptoms or diseases that are not well controlled, such as uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg), unstable angina pectoris or myocardial infarction occurring within 6 months before enrollment in the trial, or poorly controlled arrhythmias (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women, with the QTc interval calculated by the Fridericia formula), etc.;\n13. Cardiac function classified as grade III or IV according to the New York Heart Association (NYHA) classification;\n14. Those who are allergic to the components or excipients of the experimental drug, antibody drugs or any other therapeutic proteins (such as fresh frozen plasma, human serum albumin, cytokines or interleukins, etc.), or those with a history of severe allergies and suspected to have severe allergic reactions (NCI-CTCAEv5.0 ≥ grade 3);\n15. Those with a clear history of neurological or mental disorders in the past, such as dementia, and with poor compliance;\n16. Those with epilepsy and\u002For increased intracranial pressure that are difficult to control by drugs;\n17. Pregnant or lactating women;\n18. Other situations that the investigator deems unsuitable for participating in this study.",{"count":52,"type":20},40,[54],"PHASE1","The purpose of this Phase I clinical study is to evaluate the safety, preliminary efficacy and pharmacokinetic characteristics of BC008-1A injection in subjects with recurrent CNS WHO grade 4 glioma. This is a randomized and open-label study, with two dose groups set up, and 10 to 20 subjects will be enrolled in each group.",[57,58,59,60,26],"Glioma","Glioma Tumor Recurrence","Glioma, Recurrent High Grade","Glioblastomas (GBM)",[62,63,64,65,66],"glioma","PD-1","TIGIT","bispecific antibody","glioblastoma","2025-07-07",{"date":69,"type":35},"2025-07-09",{"date":71,"type":35},"2025-04-07",{"date":73,"type":20},"2026-12",{"name":75,"class":76},"Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100581031","csf-proteomic-characterization-of-glioblastomas-100581031","NCT06845020","CSF Proteomic Characterization of Glioblastomas","The Effects of CSF of Patients with Glioblastomas on the Microglial Immune Profile","Inclusion Criteria:\n\n* Patients with confirmed diagnosis of glioblastoma (histopathological and molecular).\n* Patients who voluntarily accept participation in this study.\n* Patients aged 18 or older.\n\nExclusion Criteria:\n\n* Patients who cannot be followed up at the Regional Hospital 'Dr. Valentin Gomez Farias' ISSSTE.\n* Contamination of the required sample (CSF, serum, tumor).\n* Patients with whom no sampling was obtained or subjects with incomplete background information.\n* Patients who decide to withdraw participation from the study.",{"count":85,"type":20},15,"12 Months","OBSERVATIONAL","The goal of this observational study is to identify proteins that can be found in the cerebrospinal fluid (CSF) of patients with grade IV brain tumors, specifically glioblastomas, and correlate these proteins with progression free survival, overall survival and performance status (functionality). All participants with high probability of glioblastoma will initially be included, final inclusion will be dependent on the definitive histopathological diagnosis of the tumor.\n\nThe main question is:\n\nCan the researchers identify a proteomic profile in CSF from study participants with glioblastoma in association with a longer progression free survival? Participants will undergo the following procedures, that do not deviate from normal standard diagnostic care.\n\n1. Lumbar puncture to obtain CSF.\n2. Blood draw.\n3. Trans-surgical tissue sample of the brain tumor. Additionally participants will be planned for follow up appointments every 3 months following the first 12 months after the surgical tumor resection.",[90,26,91,92,93],"Glioblastoma","Glioblastoma (GBM)","Glioblastoma Multiforme of the Brain","Glioblastoma, Adult",[90,95,96,97,98,99],"Cerebrospinal fluid","CSF","GBM","Proteomics","Biomarker","NOT_YET_RECRUITING","2025-02-21",{"date":103,"type":35},"2025-02-25",{"date":105,"type":20},"2025-03-01",{"date":107,"type":20},"2028-03-30",{"name":109,"class":42},"Univeridad Autonoma de Guadalajara"]