[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioma":36},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,147,0,25,[9,64,97,127,139,161,187,226,246,278,304,327,352,391,418,440,461,483,510,530,552,580,604,623,644],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":44,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100053479","phase-1-novel-indenoisoquinolone-cmyctopoisomerase-1-inhibitor-lmp744-in-recurrent-glioblastoma-100053479",false,"NCT07416188","Novel Indenoisoquinolone CMYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","Phase 1\u002FPhase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","* INCLUSION CRITERIA:\n\nParticipant must meet all the following inclusion criteria to be deemed eligible for this study:\n\n* Participants \\>= 18 years of age\n* Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist\n* Karnofsky Performance Status (KPS) \\>60\n* Willing to use effective birth control method\n\n  --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Agreeable to undergo craniotomy for brain biopsy and\u002For resection\n\n  --Initial diagnostic biopsy under 03-N-0164 to confirm recurrent disease and obtain pre-treatment tissue. Only participants who were not expected to able to achieve a gross total resection of tumor will be included in the study.\n* Willing and able to appoint a durable power of attorney\n* Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant and\u002For nursing females\n\n  --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and\u002For nursing females will be excluded from receiving drug\n* Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and\u002For poorly controlled congestive heart failure)\n* Social situations that would limit compliance with study requirements, such as chronic homelessness\n* Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)\n* Additional malignancy diagnosed or requiring active treatment within 1 year of screening\n* Unable to undergo an MRI scan of the brain\n* Active autoimmune disease that requires systemic treatment within 2 years of screening\n* Cardiac disease\n\n  * \\>=2 MIs\n  * \\>=2 coronary revascularization procedures\n  * Cardiac Troponin T or I \\>= 2x the institutional upper limit of normal at screening\n  * Ejection fraction \\\u003C45% on screening echocardiogram\n* Chronic hypokalemia (K\\\u003C2.5 mmol\u002FL)\n* Human Immunodeficiency Virus (HIV)\n\n  * Known history of HIV\n  * Positive HIV 1\u002F2 at screening.\n* Active Hepatitis B or Hepatitis C infection at screening\n* Active infection requiring systemic antibacterial, antiviral or antifungal therapy \\\u003C7 days prior to initiation of study drug\n* Recipient of autologous or allogeneic T cells\n* Solid organ or tissue transplant recipients","ALL","18 Years","99 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Background:\n\nGlioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.\n\nObjective:\n\nTo test LMP744 in people with glioblastoma.\n\nEligibility:\n\nPeople aged 18 years or older with glioblastoma that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.\n\nParticipants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.\n\nLMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.\n\nParticipants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.\n\nParticipants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.\n\nParticipants will continue to have telehealth visits every 3 months after they stop taking the drug.",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Recurrent Glioblastoma","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Relapsed Cancer","Recurrent Tumor","Glioblastoma Multiforme","Recurring Glioblastoma","Brain and Central Nervous System Tumors","Glioma","Glioblastomas","Grade IV Astrocytoma","GBM","Recurrent Glioma (Glioblastoma Multiforme)","High Grade Glioma","Glioma, Malignant","Brain Cancer",[29,36,45,46,47,48,49,50,43],"Neoplasms","Neoplasms, Nerve Tissue","Neoplasms by Histological Type","Glioblastoma Multiforme (GBM)","Phase I","Phase II","RECRUITING","2026-07-10",{"date":54,"type":55},"2026-07-13","ACTUAL",{"date":57,"type":22},"2026-07-16",{"date":59,"type":22},"2032-12-31",{"name":61,"class":62},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":63},"100053818","eeg-guided-cognitive-function-preservation-in-patients-with-brain-tumors-100053818","NCT07699172","EEG-Guided Cognitive Function Preservation in Patients With Brain Tumors","A Prospective Single-Arm Study of EEG-Based Neural Signal Decoding for Cognitive Function Preservation in Patients Undergoing Brain Tumor Surgery","Inclusion Criteria:\n\n* Age 18 years to 75 years.\n* Patients diagnosed with brain glioma and scheduled for surgical treatment.\n* Conscious and able to understand study procedures.\n* Able to complete neuropsychological assessments.\n* Willing to participate and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe dysfunction of major organs (heart, lung, liver, or kidney).\n* Severe psychiatric disorders or cognitive impairment.\n* Severe language impairment preventing completion of study procedures.\n* Any other condition judged by the investigator to make participation inappropriate.","75 Years",{"count":73,"type":22},10,[75],"NA","Brain tumors and their surgical treatment may impair cognitive function, affecting patients' quality of life. This prospective single-arm study aims to evaluate the feasibility and clinical utility of an EEG-based neural signal decoding strategy for cognitive function preservation in patients undergoing brain tumor surgery. Participants will undergo standardized neuropsychological assessments together with preoperative, intraoperative, and postoperative electrophysiological recordings. The study will investigate whether EEG-based neural decoding can improve objective cognitive function assessment and support individualized functional preservation during brain tumor surgery.",[36,78,79],"Brain Neoplasm","Brain Tumor Adult",[81,82,83,84,85,86],"Electroencephalography","EEG","Neural Signal Decoding","Cognitive Function","Cognitive Preservation","Brain Tumor Surgery","NOT_YET_RECRUITING","2026-07-09",{"date":54,"type":55},{"date":91,"type":22},"2026-08-01",{"date":93,"type":22},"2028-07-31",{"name":95,"class":96},"Bo Wang","OTHER",{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":17,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100053302","phase-3-clinical-benefit-of-18f-fet-in-glioma-100053302","NCT07698457","Clinical Benefit of 18F-FET in Glioma.","The Clinical Benefit of 18F-Fluoroethyl-l-tyrosine(FET) PET\u002FCT in Glioma Patients.","* Inclusion criteria： For health volunteers\n\n  1. Participants must be ≥ 20 years old.\n  2. Participants are alert and oriented, and able to independently sign ICF. For glioma patients\n\n  \u003C!-- -->\n\n  1. Participants must be ≥ 20 years old.\n  2. Participants with suspected primary gliomas scheduled for surgery.\n  3. Participants are alert and oriented, and able to independently sign ICF.\n* Exclusion criteria：\n\n  1. Liver dysfunction within the past 6 months (e.g., AST\u002FALT ratio \\> 2, total bilirubin \\> 1.5 mg\u002FdL).\n  2. Chronic kidney disease stage 4 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2) within the last 6 months.\n  3. Acute kidney injury within the past 6 months.\n  4. Allergic to any radiopharmaceuticals or contrast agents.\n  5. Restlessness or inability to lie in a cast for 30 to 60 minutes.\n  6. Women who are pregnant, lactating, or planning pregnancy during the study period or before screening.\n  7. PI deemed the participant unsuitable.\n  8. The patient is not able to understand the treatment options.",true,"20 Years",{"count":107,"type":22},36,[109],"PHASE3","This Phase II clinical trial, sponsored by \\*\\*Primo Biotechnology Co., Ltd.\\*\\*, evaluates the clinical benefit of \\*\\*$\\^{18}$F-FET PET\u002FCT\\*\\* in diagnosing glioma. The study aims to compare the diagnostic performance of $\\^{18}$F-FET PET imaging against traditional brain MRI, using surgical histopathology as the gold standard for verification.\n\n\\*\\*Study Design and Participants\\*\\* This is a single-center, open-label, non-randomized trial conducted in Taiwan. The study will enroll a total of \\*\\*36 participants\\*\\*, consisting of 6 healthy volunteers (to assess biodistribution and dosimetry) and 30 patients with suspected primary gliomas scheduled for surgery.\n\n\\*\\*Methodology\\*\\* The test drug, $\\^{18}$F-FET, is a radiopharmaceutical that targets large neutral amino acid transporters (LAT). It is administered via intravenous injection at a dosage of 3MBq\u002Fkgw.\n\n* \\*\\*Volunteers\\*\\* undergo PET\u002FCT scans immediately and every 20 minutes for 90 minutes.\n* \\*\\*Patients\\*\\* receive a static PET scan 40-50 minutes post-injection.\n\n\\*\\*Endpoints and Safety\\*\\*\n\n* \\*\\*Primary Endpoint:\\*\\* Diagnostic sensitivity compared to MRI.\n* \\*\\*Secondary Endpoints:\\*\\* Specificity, PPV, NPV, tumor-to-background ratios (TBR), and safety (adverse events\u002Fvital signs).\n* \\*\\*Radiation Safety:\\*\\* The total estimated radiation exposure is \\*\\*7.63 mSv\\*\\*, which is well below the international safety threshold of 100 mSv.\n\n\\*\\*Conclusion\\*\\* The trial seeks to establish $\\^{18}$F-FET PET\u002FCT as a safe and effective diagnostic tool for the pre-surgical assessment of gliomas, potentially providing higher sensitivity and more accurate lesion detection than conventional MRI in Asian cancer patients.",[36,112],"18F-Fluoroethyl-l-tyrosine",[114,115,116],"18F-FET","MRI","Diagnostic accuracy","2026-07-07",{"date":54,"type":55},{"date":120,"type":22},"2026-10-01",{"date":122,"type":22},"2028-01-31",{"name":124,"class":125},"Primo Biotechnology Co., Ltd","INDUSTRY",4,{"id":128,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":27,"conditions":131,"keywords":132,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":137,"leadSponsor":138,"locationsCount":63},"100624942",{"count":21,"type":22},[25,26],[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],[29,36,45,46,47,48,49,50,43],"2026-07-01",{"date":135,"type":55},"2026-07-02",{"date":117,"type":22},{"date":59,"type":22},{"name":61,"class":62},{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":63},"100594882","early-phase-1-medication-combinations-of-dasatinib-quercetin-fisetin-temozolomide-lmp744-and-autologous-tlpo-vaccine-for-the-treatment-of-previously-treated-glioma-with-residual-disease-100594882","NCT07025226","Medication Combinations of Dasatinib, Quercetin, Fisetin, Temozolomide, LMP744, and Autologous TLPO Vaccine for the Treatment of Previously Treated Glioma With Residual Disease","MC230715 Pilot Study of the Mechanistic Feedback From CNS Tumors With Latent Residual Disease to Guide Individualized Therapies","Senolytics","Inclusion Criteria - Treatment Arm (Regimens 1-8):\n\n* Age ≥ 18 years\n* Prior diagnosis of a glioma treated with chemotherapy and\u002For radiation with stable disease based on Response Assessment in Neuro-Oncology (RANO) criteria\n\n  * Must have IDH-mutant OR MGMT-methylated glioma\n\n    * NOTE: Patients with any radiographic evidence of residual disease are eligible\n* Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2, and Karnofsky performance status \\>= 50\n* Hemoglobin ≥ 9.0 g\u002FdL (≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (without transfusion ≤ 7 days preceding lab assessment) (≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN for patients with liver involvement) (≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockcroft-Gault formula (≤ 15 days prior to registration)\n* Average corrected QT interval (QTc) ≤ 450 ms on triplicate 12 lead electrocardiogram (ECG) ≤ 29 days prior to registration\n\n  * NOTE: QTc intervals will be corrected using Fridericia's formula (Fridericia 1920)\n* Negative serum pregnancy test is required for persons of childbearing potential ≤ 8 days prior to registration\n* Presence of an implanted cranial CSF access device, such as Ommaya reservoir or ventriculoperitoneal shunt\n* Willingness to provide blood and CSF samples for research\n* Co-enrollment on the neuro-oncology biorepository \\[institutional review board (IRB) 12-003458\\] for collection of research blood and CSF samples\n* Provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n\nInclusion Criteria - Monitoring Arm (Regimen 1 only):\n\n* Age ≥ 18 years\n* Prior diagnosis of a glioma\n* Negative serum pregnancy test is required for persons of childbearing potential ≤ 8 days prior to registration\n* Co-enrollment on the neuro-oncology biorepository \\[institutional review board (IRB) 12-003458\\] for collection of research blood and CSF samples\n* Provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n\nExclusion Criteria - Treatment Arm (Regimens 1-8):\n\n* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception\n* Patients who are not appropriate medical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings\n* Participants who are unable to swallow tablets or who are at risk for impaired absorption of oral medication\n\n  * NOTE: This includes but not limited to, refractory vomiting, gastric resection\u002Fbypass, or duodenal\u002Fjejunal resection\n  * NOTE: An exception can be granted for such patients if no oral medications are planned (i.e., patient will receive only IV or intradermal agents)\n* Patients with known hypersensitivity or allergy to all of the study drugs on the protocol (known hypersensitivity or allergy to one drug does not preclude participation in this protocol)\n* Inability to undergo MRI scans\n\n  * NOTE: These patients may be enrolled in the Monitoring Arm\n\nExclusion Criteria - Monitoring Arm (Regimen 1 only):\n\n* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception\n* Current or past medical history or uncontrolled concurrent illness which limits safety or compliance with study proceedings\n* Known hypersensitivity or allergy to radioactive tracers\n* Inability to undergo clinical imaging",{"count":148,"type":22},30,[150],"EARLY_PHASE1","This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin, temozolomide, LMP744, and autologous tumor lysate particle only (TLPO) vaccine work in treating patients with glioma for which the patient has received treatment in the past (previously treated) and for tumor cells that remain after attempts to treat the tumor have been made (residual disease). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Quercetin and fisetin are compounds found in plants. They have antioxidant and anti-inflammatory properties and help remove senescent cells, older or damaged cells that have stopped dividing but don't die off as they should and build up in tissues over time. Senescent cells may cause inflammation or damage to nearby healthy cells. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. LMP744 works by interfering with a protein that tumor cells use to copy and repair their DNA. By blocking this repair process, the drug causes DNA damage so that tumor cells cannot survive. The autologous TLPO vaccine is made using material from a patient's own tumor. It delivers the tumor material to immune cells so they can learn to recognize and attack the cancer. Giving medication combinations of dasatinib, quercetin, fisetin, temozolomide, LMP744, and autologous TLPO vaccine may be safe, tolerable and\u002For effective in treating patients with previously treated glioma with residual disease.",[36],"2026-06-30",{"date":135,"type":55},{"date":156,"type":55},"2025-08-12",{"date":158,"type":22},"2027-09-01",{"name":160,"class":96},"Mayo Clinic",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":63},"100609136","early-phase-1-window-trial-of-fluorescently-labeled-nivolumab-irdye800-nivo800-in-high-grade-glioma-hgg-100609136","NCT07210632","Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)","Inclusion Criteria:\n\n1. Written informed consent\n2. Age ≥ 18 years\n3. Patient must have imaging of highly suspicious high grade glioma (HGG)\n4. Patients for whom surgical craniotomy is planned as standard of care (SOC)\n5. Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion) WBC ≥ 2,000 (mcl) AST 9-80 (IU\u002FL) ALT 7-110 (IU\u002FL) BUN 6-50 (mg\u002FdL) Creatinine 0.5-3.0 (mg\u002FdL)\n\nExclusion Criteria:\n\n1. Patients not eligible for SOC surgical resection\n2. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n   Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n\n   Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n\n   Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n   Rash must cover \\\u003C 10% of body surface area Disease is well controlled at baseline and requires only low-potency topical corticosteroids No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n\n   History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n4. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n5. Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n6. Prior allogeneic stem cell or solid organ transplantation\n7. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n8. Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n   Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n\n   Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n\n   Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.\n\n   Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n\n   Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n9. Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study treatment.\n10. Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.",{"count":168,"type":22},38,[150],"High-grade gliomas (HGGs) are among the most aggressive and treatment-resistant brain tumors. Immunotherapy with checkpoint inhibitors like nivolumab has shown promise, but its efficacy remains variable and poorly understood in this patient population. This clinical trial investigates a novel imaging-enabled formulation of nivolumab-IRDye800 (nivo800) which incorporates a near-infrared (NIR) fluorescent dye to enable real-time visualization of drug distribution within tumor tissue.",[43,172,36,41,173,174,175],"HGG","High Grade Gliomas","High Grade Glioma (III or IV)","High Grade Glioma (HGG) of the Brain With BRAF Aberration",[177,178],"hgg","high grade glioma","2026-06-29",{"date":133,"type":55},{"date":182,"type":55},"2026-03-27",{"date":184,"type":22},"2031-03-30",{"name":186,"class":96},"Eben Rosenthal",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":194,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":210,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":196,"type":22},124,[25],"The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[200,36,201,202,203,204,205,172,206,207,41,208,209],"Melanoma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","LGG","Low Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[211,212,213,214,215,216,217],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600",{"date":133,"type":55},{"date":220,"type":55},"2022-11-30",{"date":222,"type":22},"2029-06-18",{"name":224,"class":125},"Pfizer",83,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":194,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":21},"100466589","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799933-in-people-with-advanced-solid-tumors-with-braf-alterations-100466589","NCT05355701","A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.","A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS","This study is seeking participants who meet the following key eligibility criteria:\n\nInclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor including primary brain tumor.\n* Qualifying BRAF alteration (V600 or non-V600 Class II\u002FClass III BRAF alteration), in tumor tissue and\u002For blood (ie circulating tumor deoxyribonucleic acid \\[DNA\\], or ctDNA).\n* Disease progressed during\u002Ffollowing last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)).\n* Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies\n* Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.\n* Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor\u002FEGFR inhibitor allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n* Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor\u002FEGFR inhibitors allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n\nExclusion Criteria:\n\n* Brain metastasis larger than 4 cm\n* Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).",{"count":234,"type":22},267,[25],"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors.\n\nThis study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called \"BRAF\" and available treatments are no longer effective in controlling their cancer.\n\nAll participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine:\n\n* People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day.\n* People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV).\n\nParticipants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.",[200,238,201,36,239],"Non-Small-Cell Lung Cancer","Advanced Colorectal Cancer (Part 1)",{"date":133,"type":55},{"date":242,"type":55},"2022-07-05",{"date":244,"type":22},"2029-10-25",{"name":224,"class":125},{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":266,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100462580","phase-3-sigma-safusidenib-in-idh1-mutant-glioma-maintenance-100462580","NCT05303519","SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","SIGMA","Key Inclusion Criteria for Part 1:\n\n1. Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient must have histologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.\n3. The IDH mutation, and other applicable gene\u002Fmolecular alterations (see Table 10-2) are determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified\u002FCollege of American Pathologists (CAP)-accredited or locally equivalent clinical laboratories. Prior clinical pathology report fulfilling the diagnosis criteria prior to screening with tumor samples collected is acceptable for patient enrollment in both Part 1 and Part 2.\n4. Patient has received no more than 2 prior therapies for disease recurrence\u002Fprogression.\n5. Patient has disease recurrence or progression or cannot tolerate the most recent therapy.\n6. Patient must have a measurable lesion(s) as per the RANO-HGG criteria for primarily enhancing lesions or RANO-LGG criteria for primarily non-enhancing lesions. The lesion (s) must be visible on 2 or more axial slices and have perpendicular diameters of at least 10 × 10 mm. The definition of primarily enhancing lesions or primarily non-enhancing lesions is referred to Section 8.3.1.\n\nKey Inclusion Criteria for Part 2 and 3:\n\n1. Must be ≥18 years old at the time of signing the ICF.\n2. Must agree to submit sufficient tumor tissue for retrospective biomarker and histological analyses. This requirement may be waived in rare circumstances with approval by the Sponsor.\n3. Has adequate hematologic and organ function\n\nKey Inclusion Criteria for Part 2:\n\n1. Diagnosis of histologically confirmed IDH1-mutant Grade 2, Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification and Investigator Assessment.\n2. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS). CDKN2A\u002FB status and at least 1 of the following must be confirmed: absence of 1p19q co-deletion by fluorescence in situ hybridization, array comparative genomic hybridization, or NGS; presence of an ATRX loss of function mutation by NGS; or loss of normal ATRX expression by IHC. A validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory must be used for all of the aforementioned results. Documentation of biomarker status, including redacted molecular pathology and NGS reports, must be provided during Screening.\n3. Must not have experienced tumor recurrence or progression between first day of radiotherapy and randomization by local assessment per RANO 2.0.\n4. Participants must have completed radiation therapy with a minimum of 80% of planned treatment completed (with or without concurrent temozolomide) and between 6 and 12 cycles of adjuvant . Randomization must occur at least 28 days and not more than 75 days after the final dose of temozolomide.\n\nKey Inclusion Criteria for Part 3:\n\n1. Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days and no longer than 5 years before the date of enrollment, have not had any other prior anticancer therapy, including chemotherapy and radiotherapy, and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.\n2. Have histologically confirmed Grade 3 IDH-mutant oligodendroglioma according to WHO 2021 criteria per local assessment.\n3. Have residual or recurrent measurable disease per RANO 2.0 and confirmed by BICR, at the time of enrollment.\n4. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL). The presence of 1p19q co-deletion must also be confirmed. All results must be generated using a validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory.\n\nKey Exclusion Criteria for Part 1:\n\n1. Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:\n2. Systemic drug therapies: within 3 weeks (lomustine within 6 weeks)\n3. Surgery: within 3 weeks\n4. Radiation therapy: within 12 weeks\n5. Investigational agents: within 5 half-lives for other investigational agents\n6. Patient did receive the prior therapy targeted to IDH1 mutation..\n7. Known hypersensitivity to safusidenib or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of safusidenib.\n\nKey Exclusion Criteria for Part 2 and 3:\n\n1. Participants with prior or anticipated treatment with anti-angiogenic agents such as Avastin (bevacizumab), agents known to target IDH1 or IDH2, or investigational agents for glioma are excluded.\n2. Have brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n3. Significant functional or neurocognitive deficits, including uncontrolled seizures, that would preclude participation in protocol-defined study activities, as assessed by Investigator.\n4. Evidence of diffuse leptomeningeal disease.\n5. History of significant cardiac disease within 12 months prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n6. If taking corticosteroids, must be on a stable or decreasing dose for the 14 days prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n7. Participants with other malignancies must have received curative treatment and been disease-free for at least 3 years. Curatively resected skin cancer or curatively treated carcinoma in situ is allowed.\n8. Have a condition that would interfere with, or increase the risk of, study participation.\n\nKey Exclusion Criteria for Part 2 1. Participants may not have received any anticancer treatments other than surgery, radiation, concurrent\u002Fadjuvant temozolomide, and tumor-treating fields. Tumor-treating fields must be discontinued prior to randomization.\n\nKey Exclusion Criteria for Part 3:\n\n1\\. Participants may not have received any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including radiotherapy.",{"count":255,"type":22},365,[109],"This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent\u002Fprogressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.\n\nThe purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.\n\nThe purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.",[36,259,260,261,262,263,264,265],"Astrocytoma, Grade IV","IDH1-mutant Glioma","Astrocytoma, IDH-Mutant, Grade 3","Astrocytoma, IDH-Mutant, Grade 4","Astrocytoma, IDH-Mutant, Grade 2","Oligodendroglioma","Oligodendroglioma, IDH-Mutant and 1p\u002F19q-Codeleted",[267,268,269],"safusidenib","IDH1-mutant glioma","astrocytoma",{"date":133,"type":55},{"date":272,"type":55},"2023-06-05",{"date":274,"type":22},"2030-12-01",{"name":276,"class":125},"Nuvation Bio Inc.",57,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":286,"studyType":287,"phases":4,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100476887","glioma-developmental-and-hyperactive-ras-tumor-dhart-board-100476887","NCT05489783","Glioma Developmental and HyperActive Ras Tumor (DHART) Board","Inclusion Criteria:\n\n* Clinical diagnosis that meets NIH criteria for NF1 disease by either 1) documented clinical record establishing NF1 or 2) self-reported with supported documentation upon medical record collection.\n* Willing to have historical and future NF1 related health records sent to registry for review.\n* Radiologic or pathologically confirmed glioma.\n* Individuals ≥18 years of age on the date of informed consent.\n\nExclusion Criteria:\n\n* Unwillingness to sign informed consent.\n* No proficiency in English or Spanish as determined by the Investigator.",{"count":285,"type":22},50,"5 Years","OBSERVATIONAL","This study will collect medical records, scan results, and complete surveys to create a registry about people with a neurofibromatosis type 1-associated brain tumor (NF1-associated glioma). A registry is a collection of health information about individuals, and it is usually focused on a specific diagnosis or condition.\n\nThis registry study will help the researchers learn more about the diagnosis, treatment, and quality of life of people with NF1-associated glioma. The researchers want to understand what happens as a result of different treatments for NF1-associated glioma and how these treatments and the disease itself affect people's lives over a period of time. Information collected during this study could affect how doctors diagnose, test, and treat NF1-associated glioma, and the study could help future patients with this type of cancer.",[36],[291,292,293,294],"NF1-associated glioma","Neurofibromatosis","Registry","22-199","2026-06-25",{"date":179,"type":55},{"date":298,"type":55},"2022-07-29",{"date":300,"type":22},"2026-07-31",{"name":302,"class":96},"Memorial Sloan Kettering Cancer Center",7,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":323,"leadSponsor":325,"locationsCount":63},"100645077","phase-2-a-study-of-hf1k16-combined-with-bevacizumab-in-patients-with-recurrent-or-progressive-glioma-100645077","NCT07678684","A Study of HF1K16 Combined With Bevacizumab in Patients With Recurrent or Progressive Glioma","A Multicenter, Open-Label, Adaptive Phase Ⅱ Clinical Study of HF1K16 Combined With Bevacizumab in Recurrent or Progressive Glioma","Inclusion Criteria:\n\n1. The patient and\u002For guardian must voluntarily sign and date a written informed consent form.\n2. Age ≥ 18 years and ≤ 75 years at the time of informed consent signing, male or female.\n3. Confirmed diagnosis of glioma by histopathology and molecular pathology, with recurrent or progressive disease following prior therapy, and no available standard treatment or intolerance to standard treatment.\n4. Expected survival time of at least 3 months.\n5. Karnofsky Performance Status (KPS) score ≥ 60.\n6. Adequate organ and bone marrow function as defined by the following criteria:\n\n   * Bone marrow reserve: absolute neutrophil count ≥ 1.5×10⁹\u002FL, platelet count ≥ 90×10⁹\u002FL, and hemoglobin ≥ 9.0 g\u002FdL (without transfusion or hematopoietic growth factor support within 14 days);\n   * Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, and international normalized ratio (INR) ≤ 1.5×ULN;\n   * Hepatic function: total bilirubin (TBIL) ≤ 1.5×ULN, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; in the presence of liver metastases, ALT and AST ≤ 5×ULN and TBIL ≤ 3×ULN;\n   * Renal function: creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n   * Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * QTcF interval on electrocardiogram \\\u003C 450 ms (males) or \\\u003C 470 ms (females).\n7. Subjects of reproductive potential (including male subjects) must agree to avoid pregnancy and use effective contraceptive measures with their partners during the study period and for 6 months after the last dose. A negative serum pregnancy test must be confirmed between screening and prior to the first dose.\n\nExclusion Criteria:\n\n1. Any active autoimmune disease, or a history of autoimmune disease requiring systemic steroid therapy, with a daily prednisone dose \\> 10 mg or equivalent corticosteroid within 2 weeks prior to study treatment.\n2. Uncontrolled seizures, hypertension, or psychiatric disorder at screening.\n3. Severe infection occurring within 4 weeks prior to the first dose, including but not limited to complicated infection requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose, except for antiviral therapy for hepatitis B or hepatitis C.\n4. Third-space effusion that cannot be effectively controlled by drainage or other measures.\n5. Participation in another clinical trial of an investigational drug within 4 weeks prior to enrollment.\n6. Receipt of any anti-tumor therapy including chemotherapy, targeted therapy, biologic therapy, immunotherapy, radical radiotherapy, or major surgery within 2 weeks prior to enrollment or within 3 half-lives (whichever is shorter).\n7. Any other active malignancy within 5 years prior to enrollment. Subjects with other malignancies cured by local therapy (e.g., basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix) are excepted.\n8. Patients with hyperthyroidism are excluded. Subjects with hypothyroidism on a stable dose of thyroid hormone replacement therapy with stable thyroid function (TSH ≤ 10 μIU\u002FmL and no clinical manifestations of hypothyroidism) may be enrolled.\n9. Failure to recover from all adverse events due to prior therapy to Grade ≤ 1 (per CTCAE v5.0) or to baseline levels, except for toxicities deemed by the investigator to pose no safety risk (such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stabilized with hormone replacement therapy, etc.).\n10. Any active cardiac disease within 6 months prior to the first dose, including New York Heart Association (NYHA) Class II-IV cardiac dysfunction, congestive heart failure, myocardial infarction, unstable angina, and\u002For stroke or other cardiovascular or cerebrovascular events of Grade 3 or higher, or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n11. HIV infection, active HBV infection (HBV DNA above the upper limit of normal), or active HCV infection (HCV RNA above the upper limit of normal).\n12. Any other serious systemic disease or any other condition that, in the opinion of the investigator, would render the subject ineligible for participation in this clinical study.",{"count":148,"type":22},[26],"The primary purpose of this Phase II study is to evaluate the preliminary anti-tumor efficacy of HF1K16 in combination with Bevacizumab in patients with recurrent or progressive glioma. The study also evaluates the safety and tolerability of the combination therapy.",[36,315],"Adult",[317,318,319],"Drug Combinations","Drug Safety","Drug Tolerance","2026-06-24",{"date":133,"type":55},{"date":153,"type":22},{"date":324,"type":22},"2028-12-31",{"name":326,"class":125},"HighField Biopharmaceuticals Corporation",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":63},"100542535","phase-1-hypofractionation-trial-of-re-irradiation-in-good-prognosis-recurrent-glioblastoma-100542535","NCT06344130","Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma","* INCLUSION CRITERIA:\n* Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.\n* Age \\>= 18.\n* KPS \\>= 70%.\n* Previous tumor irradiation to curative-intent doses.\n* Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000\u002FmicroL\n  * Platelets \\>= 100,000\u002FmicroL\n* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Recent systemic therapy prior to the initiation of the study therapy as follows:\n\n  * Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.\n  * Temozolomide within 2 weeks.\n  * Cytotoxic chemotherapy within 3 weeks.\n  * Any investigational agents within 2 weeks.\n* Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.\n* Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.\n* Requiring radiation therapy within 12 months prior to the initiation of study therapy.\n* History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.\n* Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.\n* Participants with known or suspected radiation sensitivity syndromes.\n* Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.","120 Years",{"count":336,"type":22},28,[25],"Background:\n\nGlioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.\n\nObjective:\n\nTo find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.\n\nEligibility:\n\nPeople aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.\n\nParticipants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.\n\nParticipants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.\n\nParticipants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.\n\nParticipants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.",[340,36,29],"Astrocytoma",[342,343,344],"Radiotherapy","Hypofractionation","Re-irradiation",{"date":295,"type":55},{"date":347,"type":55},"2024-10-01",{"date":349,"type":22},"2027-12-31",{"name":351,"class":62},"National Cancer Institute (NCI)",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":367,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":390},"100618049","phase-2-study-of-silevertinib-with-temozolomide-for-the-treatment-of-newly-diagnosed-gbm-with-unmethylated-mgmt-and-egfrviii-100618049","NCT07326566","Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII","A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII","Key Inclusion Criteria:\n\n* Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).\n* Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).\n* For Part 1 (Safety Lead-in) ONLY: EGFR alterations.\n* For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.\n* For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.\n* No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.\n* At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.\n\nKey Exclusion Criteria:\n\n* Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.\n* Progression of GBM prior to Enrollment, Screening, or Randomization.\n* Biopsy-only\u002Fno resectional surgery.\n* Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.\n* Intent to use Optune® (TTF).\n* Significant other uncontrolled health conditions or other malignancies.",{"count":360,"type":22},162,[26],"The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.\n\nSpecifically, this study is being done to find answers to the following questions:\n\n* How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?\n* What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)?\n* Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?",[364,365,39,48,36,366,43],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma","Central Nervous System Diseases",[368,369,370,371,372,373,374,375,376,377,378,379,380],"EGFR","Glioblastoma","Unmethylated","Unmethylated MGMT promoter","Newly Diagnosed","temozolomide","Temodar","silevertinib","BDTX-1535","EGFR alterations","epidermal growth factor receptor","EGFRvIII","epidermal growth factor receptor (EGFR)","2026-06-18",{"date":383,"type":55},"2026-06-22",{"date":385,"type":55},"2026-05-05",{"date":387,"type":22},"2029-03",{"name":389,"class":125},"Black Diamond Therapeutics, Inc.",14,{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":398,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":405,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":63},"100642670","movie-watching-functional-mri-for-mapping-brain-function-in-neurosurgical-patients-100642670","NCT07650994","Movie-Watching Functional MRI for Mapping Brain Function in Neurosurgical Patients","Naturalistic Neuroimaging for Neurosurgical Brain Mapping","Inclusion Criteria:\n\n* Any sex, age between 21 to 70 years;\n* Known or suspected glioma (lesion) of the brain;\n* English speaking;\n* Patients with clinical fMRI scheduled (or pending scheduling) for presurgical planning at BWH ordered by a BWH clinician;\n* Passes prescreening and standard of care screenings for 3 Tesla MRI;\n* Willing to participate in the additional study scan and neuropsychological assessment visit;\n* Informed consent form signed by the subject or legally acceptable representative.\n\nExclusion Criteria:\n\n* Contraindications to MRI: Note: MRI screening will be performed by radiology staff as part of their standard process for their clinical scans and if subjects do not pass the screen, MRI will not be performed.\n* Pregnancy or possible pregnancy: Female participants under 55 (or 45 with menstrual cycle in the past 12 months) who may be pregnant. Per policy: potential subjects will be asked if they are pregnant and excluded if they say yes. If unsure, pregnancy testing will be performed. Any subjects with positive result will be excluded.","21 Years","70 Years",{"count":401,"type":22},90,[75],"This research will compare a new type of functional MRI (fMRI) called naturalistic viewing (also called movie watching) to standard clinical fMRI techniques. Standard clinical fMRI currently uses multiple tasks such as reading and responding to words or sentences to determine which areas of the brain are responsible for language. Surgeons can use this information to help plan brain surgeries. This research will help determine if the movie-watching fMRI is equivalent or better than the standard task-based fMRI. If so, it could be useful for planning patients' surgeries in the future, without the need for multiple tasks.",[36,79],[406,407,408,409],"Movie Functional Magnetic Resonance Imaging","Clinical Functional Magnetic Resonance Imaging","Presurgical Planning","Presurgical Brain Mapping","2026-06-17",{"date":383,"type":55},{"date":413,"type":22},"2026-09-01",{"date":415,"type":22},"2029-03-31",{"name":417,"class":96},"Brigham and Women's Hospital",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":63},"100485925","phase-2-methimazole-in-patients-with-progressive-glioblastoma-100485925","NCT05607407","Methimazole in Patients With Progressive Glioblastoma","Targeting Transsulfuration Via Suppression of Thyroid Hormone Signaling in Progressive Glioblastoma: Phase 2 and Pharmacodynamic Trial of Methimazole in Patients With Progressive Glioblastoma","Inclusion Criteria:\n\n* Subjects must have histologically or cytologically confirmed WHO grade 4 glioma (including tumors with molecularly defined grade 4 astrocytoma) for which a clinically indicated tumor resection is planned.\n* Subjects must not have received methimazole for this disease.\n* Age is greater than or equal to 18 years of age\n* Performance status: Karnofsky Performance status ≥ 70%\n* Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below: Hemoglobin ≥ 8 g\u002Fdl, Absolute neutrophil count ≥ 1,200\u002FmcL, Platelet count ≥ 75,000\u002FmcL, Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN), AST (SGOT) ≤ 3 X institutional ULN, ALT (SGPT) ≤ 3 X institutional ULN, Calculated creatinine clearance \\> 50 mL\u002Fmin, Prothrombin time\u002Finternational normalized ratio (PT\u002FINR) \\\u003C1.4 for patients not on warfarin, Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria: No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices), In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\n* Subjects must have normal thyroid function within 21 days of study entry as defined below: ≤ 3 X institutional ULN\n* Women of childbearing potential must have a negative pregnancy test within 21 days of study entry. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men of reproductive potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.\n* Patients must be able to swallow whole tablets.\n* Patients must have the following minimum intervals from prior treatments: surgery - 4 weeks, nitrosoureas - 6 weeks, cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose. For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval, Investigational therapy or non-cytotoxic therapy - 2 weeks, For bevacizumab - 4 weeks from anticipated date of protocol surgery\n* Patients positive for human immunodeficiency virus (HIV) are allowed on study (note: HIV testing is not required), but HIV-positive patients must have: An undetectable viral load within 6 months of registration, A stable regimen of highly active anti-retroviral therapy (HAART), No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patient must be deemed by investigator to be a candidate for post-operative chemotherapy.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia and neuropathy.\n* Subjects receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to methimazole.\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Other prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are excluded. Otherwise, patients with prior or concurrent malignancy are eligible.\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 (National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events Version 5.0 \\[CTCAE v.5.0\\] diarrhea of any etiology at screening).\n* Pregnant or breastfeeding.\n* Known history of hyperthyroidism or hypothyroidism\n* Unable or unwilling to swallow tablets.\n* Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness\u002Fsocial situations that would, in the Investigator's judgment, make the patient inappropriate for this study.",{"count":426,"type":22},19,[26],"The purpose of this study is to test the effectiveness, safety, and tolerability of a drug called Methimazole. The investigational drug, Methimazole is not FDA approved for brain tumors, but it is used to treat thyroid illnesses. Different doses of Methimazole will be given to several study participants with glioblastoma. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until the side effects occur that require the dose to be lowered. The procedures in this study are research blood draws, physical exams, collection of medical history, MRI scans, and study drug administration.",[369,36],[431,432],"Transsulfuration","Methimazole",{"date":381,"type":55},{"date":435,"type":55},"2023-01-30",{"date":437,"type":22},"2026-09",{"name":439,"class":96},"Case Comprehensive Cancer Center",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":447,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":63},"100342498","phase-1-hyperpolarized-imaging-in-diagnosing-participants-with-glioma-100342498","NCT03739411","Hyperpolarized Imaging in Diagnosing Participants With Glioma","Pilot Study of Safety and Feasibility of Acquiring Hyperpolarized Imaging in Patients With Gliomas","Inclusion Criteria:\n\nFor Participants in Cohort 1: Suspected or histologically proven glioma who have evidence of evaluable disease based on a prior magnetic resonance (MR) scan.\n\nFor Participants in Cohort 2: Histologically proven glioma who will be undergoing treatment.\n\nTo be included in the study all subjects must also meet the following criteria:\n\n1. Participants must be \\> 18 years old and with a life expectancy \\> 12 weeks.\n2. Participants must have a Karnofsky performance status of ≥ 60.\n3. Participants must have adequate renal function (creatinine \\\u003C 1.5 mg\u002FdL) before starting therapy. This tests must be performed within 60 days prior to Hyperpolarized Imaging scan.\n4. Participants must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent.\n5. Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure\n6. Participants must not have a history of myocardial infarction or unstable angina within 12 months prior to study enrollment.\n7. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.\n8. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.\n9. Participants may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation.\n10. Participants must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.\n11. Participants must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential.\n\nExclusion Criteria:\n\n1\\. Participants must be excluded from participating in this study if they are not able to comply with study and\u002For follow-up procedures.","19 Years",{"count":449,"type":22},140,[25],"This pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.",[36],"2026-06-16",{"date":381,"type":55},{"date":456,"type":55},"2015-12-09",{"date":458,"type":22},"2028-06-01",{"name":460,"class":96},"Susan Chang",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":63},"100634599","phase-1-sitagliptin-in-recurrentprogressive-grade-4-glioma-100634599","NCT07541781","Sitagliptin in Recurrent\u002FProgressive Grade 4 Glioma","Targeting Myeloid-Derived Suppressor Cells in Patients With Recurrent\u002FProgressive Grade 4 Glioma: Phase 1 Trial of Sitagliptin","Inclusion Criteria:\n\nPhase 1b\n\n* Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence\u002Fprogression after first line therapy is diagnosed by the treating physician.\n* Subjects must not have received sitagliptin or bevacizumab for this disease.\n* Age \\>18 years\n* Performance status: ECOG performance status 0-2\n* Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:\n\n  1. Hemoglobin ≥ 9 g\u002Fdl\n  2. Absolute neutrophil count ≥ 1,500\u002FmcL\n  3. Platelet count ≥ 100,000\u002FmcL\n  4. Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN)\n  5. AST (SGOT) ≤ 3 X institutional ULN\n  6. ALT (SGPT) ≤ 3 X institutional ULN\n  7. Calculated creatinine clearance \\> 50 mL\u002Fmin\n  8. Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio.\n\n     For UPC ratio \\> 0.5, 24-hour urine protein must be obtained and must be \\\u003C 1000 mg.\n  9. Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:\n\n     * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\n     * In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days prior to treatment start. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.\n* Subjects must be able to swallow whole tablets.\n* Participants must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy\n* Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study treatment\n* Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1 Day 1:\n\n  * surgery - 4 weeks\n  * nitrosoureas - 6 weeks\n  * cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose.\n  * For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.\n  * Investigational therapy or non-cytotoxic GBM related therapy - 2 weeks\n* Subject is not deemed as a surgical candidate.\n\nPilot Phase\n\n* Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence\u002Fprogression after first line therapy is diagnosed by the treating physician.\n* Subjects must not have received sitagliptin or bevacizumab for this disease.\n* Age \\>18 years\n* Performance status: ECOG performance status 0-2\n* Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:\n\n  1. Hemoglobin ≥ 9 g\u002Fdl\n  2. Absolute neutrophil count ≥ 1,500\u002FmcL\n  3. Platelet count ≥ 100,000\u002FmcL\n  4. Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN)\n  5. AST (SGOT) ≤ 3 X institutional ULN Version date: 30March2026 Page 16\n  6. ALT (SGPT) ≤ 3 X institutional ULN\n  7. Calculated creatinine clearance \\> 50 mL\u002Fmin\n  8. Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio.\n\n     For UPC ratio \\> 0.5, 24-hour urine protein must be obtained and must be \\\u003C 1000 mg.\n  9. Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:\n\n     * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\n     * In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days of treatment start. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.\n* Subjects must be able to swallow whole tablets.\n* Subjects must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy\n* Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to treatment start\n* Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1Day1:\n\n  * surgery - 4 weeks\n  * nitrosoureas - 6 weeks\n  * cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose.\n  * For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.\n  * Investigational therapy or GBM related non-cytotoxic therapy - 2 weeks\n  * For bevacizumab (if for a different cancer) - 4 weeks from the expected date of protocol surgery\n* Subject is deemed as a surgical candidate.\n\nExclusion Criteria (for phase 1b and pilot phase)\n\n* Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except for alopecia and neuropathy.\n* Subjects receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin or bevacizumab.\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Known HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sitagliptin and\u002For bevacizumab. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy.\n* Other malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or vulva; c) prostate cancer of Gleason Score 6 or less with stable prostate specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, or benign tumors of the adrenal or pancreas.\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 (National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events Version 5.0 \\[CTCAE v.5.0\\] diarrhea of any etiology at screening).\n* Known active infection with hepatitis B or hepatitis C virus.\n* Pregnant or breastfeeding.\n* Subjects who receive insulin or sulfonylurea for diabetes mellitus.\n* Subjects with history of type 1 diabetes, uncontrolled type 2 diabetes, hypoglycemia requiring medical intervention, or those who are deemed not suitable to receive sitagliptin at the discretion of the investigators.\n* Unable or unwilling to swallow tablets.\n* Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness\u002Fsocial situations that would, in the Investigator's judgment, make the patient inappropriate for this study.\n* Arterial ischemic event (e.g., unstable angina, myocardial infarction, stroke) within 6 months of study consent.\n* Subjects with history of hematologic bleeding disorder.",{"count":469,"type":22},45,[25],"Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas that have returned or progressed after treatment, and 2) find out what the highest dose of sitagliptin is appropriate to give when combined with bevacizumab.",[36,369,473,29,474],"Recurrent Glioma","Grade 4 Malignant Glioma of Brain (Disorder)","2026-06-15",{"date":410,"type":55},{"date":478,"type":55},"2026-06-11",{"date":480,"type":22},"2030-06-11",{"name":482,"class":96},"Kailin Yang, MD, PhD",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":490,"maxAge":398,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":509},"100367552","evaluation-of-hippocampal-avoidance-using-proton-therapy-in-low-grade-glioma-100367552","NCT04065776","Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma","A Phase II Study of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma","Inclusion Criteria:\n\n* Patients must have a diagnosis of pilocytic astrocytoma, pilomyxoid astrocytoma, pleomorphic xanthoastrocytoma, ganglioglioma, optic pathway glioma, diffuse astrocytoma, low-grade neuroepithelial tumor, low-grade glioneuronal tumor or LGG, or not otherwise specified (NOS).\n* Patient with eligible diagnosis other than optic pathway glioma or tumors of the brainstem\u002Fmidbrain\u002Ftectum has histologic verification of disease at diagnosis or recurrence OR\n* Patient with optic pathway glioma or tumors of the brainstem\u002Fmidbrain\u002Ftectum has radiologic verification of disease at diagnosis or recurrence\n* A repeat biopsy was done because the recurrent tumor was enhancing but did not originally enhance because there was a high index of suspicion regarding high-grade transformation\n* Tumor must be located in the suprasellar region or midline structures. Midline structures include, but are not limited to, the thalamus, basal ganglia, internal capsule, midbrain, tectum, third ventricle, fourth ventricle, cerebellum, pons, and medulla. Tumors may involve the optic pathway. For questions about tumor locations that are not specified on this list, please contact the Study PI.\n* Patients must be at least 6 years but less than 22 years of age at the time of enrollment.\n* Patients must have a performance status greater or equal to 70 (use Karnofsky scale for patients aged 16 years and older and Lansky scale for patients aged less than 16 years).\n* Patients may not receive concurrent chemotherapy or targeted therapy, including but not limited to BRAF-inhibitors and MEK-inhibitors.\n* All patients must be able to undergo contrast-enhanced brain MRI.\n* All patients must have adequate organ function as described below.\n\n  * Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FµL\n  * Platelet count ≥ 10,000\u002FµL (transfusion independent)\n  * Patients with seizures may be enrolled if well controlled on anticonvulsants\n\nExclusion Criteria:\n\n* Patients may not have received prior CNS radiation.\n* Patients with gross total resection and no measurable disease via MRI are not eligible. Patients must have measurable disease of at least 1 cm via MRI.\n* Patients with evidence of metastatic disease are not eligible.\n* Patients with WHO grade II midline tumors that harbor the H3K27M mutation, IDH-mutant gliomas, grade II ependymomas and subependymomas, pituicytomas, spindle cell oncocytomas, or granular cell tumors of the sellar region are not eligible.\n* Patients with tumors that directly invade the hippocampus or with gross tumor volumes that extend into the hippocampus are not eligible.\n* Patients with tumors in the spine or cervicomedullary junction.\n* Females of child-bearing potential cannot be pregnant or breast feeding. Female participants \\> 10 years of age or post menarche must have a negative serum or urine pregnancy test before enrollment. Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.\n* Patients who are status post resection of bilateral hippocampi. Patients who are status post resection of one hippocampus will be eligible for the study and the hippocampal dose constraints will be applied to the intact hippocampus.","6 Years",{"count":492,"type":22},74,[75],"Low-grade gliomas (LGGs) are the most common brain tumors in children, and a subset of these tumors are treated definitively with focal radiation therapy (RT). These patients often survive for many years after receiving RT and experience late deficits in memory. Verbal recall is an important measure of memory and is associated with other important functional outcomes, such as problem-solving, independence of every-day functioning, and quality of life. Decline in memory, as measured by verbal recall, is associated with RT dose to the hippocampi. Therefore, this phase II study investigates the feasibility of reducing RT doses to the hippocampi (i.e., hippocampal avoidance \\[HA\\]) by using proton therapy for midline or suprasellar LGGs.\n\nPrimary Objective:\n\n* To determine the feasibility of HA with proton therapy in suprasellar or midline LGGs. Feasibility will be established if 70% of plans meet the first or second dose constraints shown below.\n\n  1. First priority RT dose constraints for bilateral hippocampi: volume receiving 40 CGE (V40CGE) ≤ 25%, dose to 100% of Hippocampus (D100%) ≤ 5CGE.\n  2. Second priority RT dose constraints for bilateral hippocampi: V40CGE ≤ 35%, D100% ≤ 10 CGE.\n\n     Secondary Objectives:\n* To estimate the 3-year event-free-survival (EFS) for LGGs treated with HA.\n* To estimate the change in California Verbal Learning Test short-term delay (CVLT-SD) from baseline to 3 years and from baseline to 5 years\n* To compare CVLT-SD and Cogstate neurocognitive scores in patients with proton therapy plans that: (1) meet first priority RT dose constraints, (2) meet second priority RT dose constraints but not first priority RT dose constraints, and (3) that did not meet either first or second RT priority dose constraints\n\nExploratory Objectives:\n\n* To describe the change in overall cognitive performance from baseline to 3 years and from baseline to 5 years with an age appropriate battery, including gold standard measures shown in the published studies to be sensitive to attention, memory processing speed and executive function that will afford comparison to historical controls.\n* To characterize longitudinal changes in connection strength within brain networks in the first 3 years after proton therapy and to investigate associations between these changes and neurocognitive performance with focus on the hippocampi.\n* To correlate the distribution and change in L-methyl-11C-methionine positron emission tomography (MET-PET) uptake to tumor progression and from baseline to 3 years and to investigate whether cases of pseudoprogression exhibit a differential pattern of uptake and distribution compared to cases of true progression after controlling for histology.\n* To investigate the effect of BRAF alteration, tumor histology and tumor location on PFS and OS in a prospective cohort of patients treated in a homogenous manner.\n* To investigate whether the methylation profiles of LGGs differ by tumor location (thalamic\u002Fmidbrain vs. hypothalamic\u002Foptic pathway vs. others) and histologies (pilocytic astrocytoma vs. diffuse astrocytoma vs. others), which, in conjunction with specific genetic alterations, may stratify patients into different subgroups and highlight different therapeutic targets.\n* To record longitudinal measures of circulating tumor DNA (ctDNA) in plasma and correlate these measures with radiographic evidence of disease progression.\n* To bank formalin-fixed, paraffin-embedded (FFPE)\u002Ffrozen tumors and whole blood from subjects for subsequent biology studies not currently defined in this protocol.\n* To quantify and characterize tumor infiltrating lymphocytes (TILs) and to characterize the epigenetics of T cells and the T cell receptor repertoire within the tumor microenvironment.\n* To estimate the cumulative incidence of endocrine deficiencies, vision loss, hearing loss and vasculopathy after proton therapy and compare these data to those after photon therapy.",[36,496,497,498,499,500,501],"Pilocytic Astrocytoma","Pilomyxoid Astrocytoma","Pleomorphic Xanthoastrocytoma","Ganglioglioma","Optic Pathway Glioma","Diffuse Astrocytoma",{"date":410,"type":55},{"date":504,"type":55},"2019-08-28",{"date":506,"type":22},"2028-07",{"name":508,"class":96},"St. Jude Children's Research Hospital",2,{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":104,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":23,"phases":519,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":509},"100560308","using-the-epitranscriptome-to-diagnose-and-treat-gliomas-100560308","NCT06575452","Using the Epitranscriptome to Diagnose and Treat Gliomas","EPIGLIO","Inclusion Criteria:\n\n* Male \u002F female over 18 years of age,\n* Surgery (tumor resection) scheduled at Montpellier University Hospital for suspected, diffuse glioma, confirmed on tissue sample: IDH mutated grade 2 glioma (excluding tumors with a focus of grade 3 or 4 glioma), IDH mutated grade 3 glioma or GBM, IDH wild-type,\n* No history of treatment (surgery, radiotherapy or chemotherapy) for glioma,\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\n* Patient has given express written informed consent prior to any study procedure,\n* Patient affiliated to a French health insurance.\n\nExclusion Criteria:\n\n* Patients whose regular follow-up is impossible for psychological, family, social or geographical reasons,\n* Patients under guardianship, curatorship or safeguard of justice,\n* Pregnant and\u002For breast-feeding patient (information gathered from the medical file, as part of the patient's standard medical care and follow-up),\n* Histo-molecular diagnosis of grade 4 IDH-mutated astrocytoma,\n* For grade 2 gliomas, presence within the tumor of one or more higher-grade sites (3 or 4).",{"count":518,"type":22},228,[75],"Diffuse gliomas are among the most common tumors of the central nervous system, with high morbidity and mortality and very limited therapeutic possibilities. The diffuse glioma are characterized by significant variability in terms of age at diagnosis, histological and molecular features, classification, ability to transform to a higher grade and\u002For to disseminate in the brain, response to treatment and patient outcome.\n\nOne of the main challenges in the management of diffuse gliomas is related to tumor heterogeneity within the same subgroup. Establishing an accurate tumor classification is of paramount importance for selecting personalized therapy or avoiding unnecessary treatment.\n\nAt present, the main diagnostic methods for detecting gliomas are based on histopathological features and mutation detection. Yet difficulties remain, due to tumor heterogeneity and sampling bias for tumors obtained from small biopsies. In particular, grade 2 (low-grade) and grade 3 (high-grade) gliomas cannot be easily distinguished, as intra-tumoral tumor grade heterogeneity is not uncommon in patients treated with extensive surgical resection. Another challenge in the field of gliomas is longitudinal monitoring of disease progression, which is currently mainly based on repeated brain Magnetic Resonance Imaging (MRI). New tools to detect tumor changes before the onset of imaging changes would be useful.\n\nSeveral genetic, epigenetic, metabolic and immunological profiles have been established for gliomas. Recently, the world of RiboNucleic Acid (RNA) has emerged as a promising area to explore for cancer therapy, especially since the (re)discovery of RNA chemical modifications. To date, more than 150 types of post-transcriptional modifications have been reported on various RNA molecules. This complex landscape of chemical marks embodies a new, invisible code that governs the post-transcriptional fate of RNA: stability, splicing, storage, translation.",[36],"2026-06-09",{"date":478,"type":55},{"date":525,"type":55},"2026-06-01",{"date":527,"type":22},"2031-05",{"name":529,"class":96},"Institut du Cancer de Montpellier - Val d'Aurelle",{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":537,"targetDuration":4,"studyType":287,"phases":4,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":63},"100483520","longitudinal-prospective-study-of-neurocognition--neuroimaging-in-primary-bt-patients-100483520","NCT05576103","Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients","Longitudinal Prospective Study of Neurocognitive Outcomes and Multimodal Quantitative Neuroimaging Outcomes in Primary Brain Tumor Patients Receiving Brain Radiotherapy","Inclusion Criteria:\n\n1. Patients 18 years or older\n2. Karnofsky performance status (KPS) ≥70\n3. Life expectancy of ≥1 year\n4. Primary brain tumor patients who will receive fractionated partial brain RT\n5. Able to complete neurocognitive assessments\n\nExclusion Criteria:\n\n1. Inability to undergo MRI with contrast\n2. Prior brain RT",{"count":538,"type":22},300,"In this proposal, the investigators introduce a novel, translational study to prospectively examine primary brain tumor patients undergoing fractionated radiation therapy to the brain. Quantitative neuroimaging, radiation dose information, and directed neurocognitive testing will be acquired through this study to improve understanding of cognitive changes associated with radiation dosage to non-targeted tissue, and will provide the basis for evidence-based cognitive- sparing brain radiotherapy.",[541,36,542,543],"Primary Brain Tumor","Meningioma","Schwannoma",{"date":545,"type":55},"2026-06-10",{"date":547,"type":55},"2015-01",{"date":549,"type":22},"2030-12",{"name":551,"class":96},"Jona Hattangadi-Gluth",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":568,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":4},"100643228","early-phase-1-evaluation-of-galuht547-safety-biodistribution-and-dosimetry-in-solid-tumors-100643228","NCT07639970","Evaluation of [⁶⁸Ga\u002F¹⁷⁷Lu]HT547: Safety, Biodistribution, and Dosimetry in Solid Tumors","Evaluation of the Safety, Biodistribution and Human Dosimetry of [68Ga]Ga-HT547 PET\u002FCT and [177Lu]Lu-HT547 SPECT\u002FCT in the Clinical Diagnosis of Solid Tumor Patients","Inclusion Criteria:\n\n1. Willing and able to communicate with the investigator, understand and comply with trial requirements, voluntarily participate in the trial, and provide written informed consent.\n2. Aged 18 years or older, regardless of gender.\n3. Expected survival of at least 3 months.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. Patients with solid tumors (breast cancer, head and neck cancer, pancreatic cancer, or brain glioma) confirmed by histology or cytology.\n6. Radiographic evidence of disease progression within 12 months prior to screening (according to RECIST 1.1 criteria).\n7. At least one measurable target lesion according to RECIST 1.1 criteria.\n8. Positive uptake in the target lesion on ⁶⁸Ga-HT547 Positron Emission Tomography (PET) scan, with SUV ≥ 4.\n9. Recovery from toxicities related to prior therapy to ≤ Grade 1 or baseline (except for alopecia, vitiligo, etc.).\n10. For subjects of childbearing potential: Agreement to remain abstinent or use effective contraception (including intrauterine devices, etc.) from signing the ICF until at least 24 weeks after the last dose.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women with a positive baseline pregnancy test.\n2. History of severe allergic reaction to any component of the investigational drug injection.\n3. Received blood transfusion within 4 weeks prior to screening to meet the enrollment criteria.\n4. Received immunotherapy, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.\n5. Received any investigational drug within 28 days prior to the first dose, or concurrent participation in another clinical study (except: participation in an observational, non-interventional study, or being in the follow-up phase of an interventional study).\n6. History of other known malignancies within the past 5 years.\n7. Presence of symptomatic or unstable third-space effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.\n8. Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.\n9. Inadequate organ function (meeting any of the following):\n\n   1. Bone marrow reserve: Neutrophil count \\\u003C 1.5 x 10⁹\u002FL, or platelet count \\\u003C 100 x 10⁹\u002FL, or hemoglobin \\\u003C 90 g\u002FL.\n   2. Liver function: AST\u002FALT \\> 3 x ULN (\\> 5 x ULN for subjects with liver metastases), or albumin ≤ 2.8 g\u002FdL, or total bilirubin \\> 1.5 x ULN.\n   3. Renal function: Serum creatinine \\> 1.5 x ULN and creatinine clearance \\\u003C 60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n10. Severe cardiovascular clinical diseases or symptoms that may increase subject safety risk, including:\n\n    1. Congestive heart failure (New York Heart Association \\[NYHA\\] class \\> II) within the past year.\n    2. Unstable angina within the past year.\n    3. Myocardial infarction within the past year.\n    4. Clinically significant malignant arrhythmia (except for atrial fibrillation, paroxysmal supraventricular tachycardia).\n    5. Presence of clinically significant QTcF prolongation (QTcF \\> 470 ms, calculated by Fridericia's formula).\n11. Clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 14 days prior to the first dose.\n12. Major surgery or significant trauma within 28 days prior to the first dose.\n13. Any other condition that, in the investigator's judgment, may increase safety risk or interfere with its interpretation.\n14. Inability of the subject to understand and comply with study instructions and requirements.\n15. Any other situation deemed inappropriate by the investigator.","90 Years",{"count":561,"type":22},20,[150],"Urokinase plasminogen activator receptor (uPAR), the cell-surface receptor for its ligand uPA, plays a critical role in regulating cell migration and invasion-key drivers of cancer progression. This study aims to evaluate a novel uPAR-targeting radiopharmaceutical pair: the diagnostic agent \\[⁶⁸Ga\\]Ga-HT547 and the therapeutic agent \\[¹⁷⁷Lu\\]Lu-HT547. In patients with breast cancer, head and neck cancer, pancreatic cancer, or glioma, we will assess the diagnostic performance and biodistribution of these tracers using \\[⁶⁸Ga\\]Ga-HT547 and \\[¹⁷⁷Lu\\]Lu-HT547 SPECT\u002FCT.",[565,566,567,36],"Breast Cancer","Head and Neck Cancer (H&N)","Pancreatic Cancer",[569,570,571],"Urokinase plasminogen activator receptor","Cancer","Radiopharmaceutical","2026-06-08",{"date":545,"type":55},{"date":575,"type":22},"2026-06",{"date":577,"type":22},"2027-10",{"name":579,"class":96},"Hua Pang",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":603},"100628690","phase-1-a-phase-1-safety-and-dose-finding-study-of-glix1-in-adults-with-recurrent-or-progressive-high-grade-glioma-100628690","NCT07464925","A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","Main Inclusion Criteria:\n\n* Adult patients aged ≥18 years at the time of informed consent\n* Participants must have histologically confirmed Grade 3 or Grade 4 glioma\n* Recurrent or progressive disease\n* A maximum of two prior treatment lines\n* Interval of at least 3 months since the last day off of radiotherapy, unless tumor progression and index lesion is outside the prior radiation field.\n* Interval since last dose of systemic therapy and Baseline MRI of ≥28 days, except:\n\n  * for nitrosoureas (e.g., lomustine, carmustine, fotemustine): 42 days (6 weeks)\n  * for monoclonal antibodies: 42 days (6 weeks)\n  * for small molecules, 4 weeks or at least 5 half-lives (whatever is longer)\n* Recovered from all toxicities from prior treatments to Grade 1 or less by NCI CTCAE v6.0:\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤6 mg daily dexamethasone (or ≤40 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n* Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n* Ability to swallow tablets or capsules.\n* Adequate hematological, liver and renal function.\n* Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to first dosing. Women must use a highly effective form of contraception (with Pearl Index \\\u003C1%) for the duration of the study and for at least 3 months after the last dose of study medication.\n* Men with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception by the partner during the study and for at least 3 months after the last dose of study medication.\n\nMain Exclusion Criteria:\n\n* Known contraindication for gadolinium (Gd) based, contrast-enhanced MRI\n* Prior history of another invasive malignancy unless a complete remission was achieved at least 3 years prior to enrolment AND no additional therapy is required during the study period, except for anti-estrogen or androgen therapy and\u002For bisphosphonates or denosumab.\n* Participants with known active or uncontrolled infection, and\u002For unexplained fever \\>38°C in the 3 days prior to the start of study treatment.\n* Major non-tumor related surgical procedure or significant traumatic injury within 28 days prior to signing of consent.\n* Receiving any investigational products (defined as treatment for which there is currently no regulatory authority-approved indication) within 4 weeks or 5 half-lives (whichever is the longest) prior to Baseline MRI.",{"count":148,"type":22},[25],"This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as monotherapy by reviewing safety and tolerability, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated.\n\nPatients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.",[591,36,369],"Glioblastoma Multiforme of Brain",[593,36,39,369,594],"GLIX1","TET2","2026-06-07",{"date":522,"type":55},{"date":598,"type":55},"2026-04-20",{"date":600,"type":22},"2027-12",{"name":602,"class":125},"Tetragon Biosciences Ltd",3,{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":287,"phases":4,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":63},"100583967","three-mirna-signatures-in-glioma-from-molecular-mechanisms-to-potential-clinical-application-100583967","NCT06883214","Three miRNA Signatures in Glioma: From Molecular Mechanisms to Potential Clinical Application","Deciphering the Functional Role of a Three-miRNA Signature in Glioma: From Molecular Mechanisms to Potential Clinical Application","Inclusion Criteria:\n\n* histological diagnosis of glioma;\n* no concomitant primary tumor;\n* no metastatic disease;\n* availability of surgical material\u002Ftissue;\n* written informed consent.\n\nExclusion Criteria:\n\n* histological diagnosis of non-glial tumor;\n* patients with concomitant other solid tumors;\n* metastatic disease;\n* no surgical material\u002Ftissue available;\n* HIV seropositivity.",{"count":73,"type":22},"Individual overexpression of the three miRNAs negatively affects cell viability and proliferation mainly in grade III IDH-wild type cells, while in higher grade cells, the effect is more pronounced when the entire signature is overexpressed, individual and combined overexpression of the signature members is able to determine a significant reduction in both migration and invasion. Therefore, ectopic expression of the miRNAs identified by us has a negative impact on cell viability, proliferation and apoptosis, but above all on migration and invasion.",[36],"2026-06-04",{"date":616,"type":55},"2026-06-05",{"date":618,"type":55},"2023-01-17",{"date":620,"type":22},"2027-01-17",{"name":622,"class":96},"Regina Elena Cancer Institute",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":447,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":631,"briefSummary":632,"conditions":633,"keywords":634,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":509},"100516943","phase-1-treatment-of-patients-with-recurrent-high-grade-glioma-with-apg-157-and-bevacizumab-100516943","NCT06011109","Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab","A Pilot Study of APG-157 With Bevacizumab for Patients With Recurrent High-Grade Glioma","Inclusion Criteria:\n\n1. Patients must have pathologically proven diagnosis of high grade (aka grade III or IV) glioma that has progressed on bevacizumab (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma, H3K27M mutant glioma).\n2. Patients must have received prior radiation therapy and standard temozolomide. Patients who have received any number of therapies for previous progressions will be considered eligible.\n3. Patients must be three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression.\n4. Physiologic Status\u002FAge: Patients must be 19 years of age or older (the age of consent in Nebraska.)\n5. Patients must have recovered from any toxicity of prior therapy to Grade 1 or less.\n6. ECOG Performance Status of 0-3.\n7. Patients must have an adequate bone marrow reserve (ANC count ≥1,500\u002Fmm3, hemoglobin \\> 8 g\u002FdL, platelet count ≥100,000\u002Fmm3).\n8. Patients must have adequate renal and hepatic function with:\n\n   1. creatinine \\\u003C 1.5 x institutional upper limit of normal (ULN).\n   2. total bilirubin \\\u003C 1.5 x ULN (unless due to Gilbert's disease)\n   3. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C2.5 x ULN\n   4. serum alkaline phosphatase less than 2.5 times the upper limits of normal)\n9. The patient must willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.\n10. Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment.\n11. Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study. (Non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and\u002For both ovaries).\n\nExclusion Criteria:\n\n1. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral APG-157, or put the study outcomes at undue risk\n2. Immunotherapy, chemotherapy, radiotherapy, or experimental therapy within one full cycle period before first dose of study drug (i.e., for lomustine 6 weeks, for temozolomide 4 weeks)\n3. Lactating or pregnant\n4. History of uncontrollable allergic reactions to bevacizumab\n5. Clinically Significant Cardiovascular Disease Defined as follows:\n\n   * Inadequately controlled hypertension (i.e., systolic blood pressure (SBP) \\> 160 mm Hg and\u002For diastolic blood pressure (DBP) \\> 90 mm Hg despite antihypertensive therapy)\n   * History of cerebrovascular accident (CVA) within 6 months\n   * Myocardial infarction or unstable angina within 6 months\n6. Evidence or history of bleeding diathesis (greater than normal risk of bleeding, i.e., Hereditary Hemorrhagic Telangiectasia type I or HHT-1) or coagulopathy in the absence of therapeutic anti-coagulation or any hemorrhage\u002Fbleeding event \\> Grade 3 within 4 weeks prior to registration. Note: Patients with full-dose anticoagulants are eligible provided the patient has been on a stable dose for at least 2 weeks\n7. Active wound, a serious or non-healing wound, an active ulcer or untreated bone fracture within the last two months.\n8. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess ≤ 6 months prior to registration.\n9. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days prior to registration\n10. Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent",{"count":148,"type":22},[25,26],"The goal of this interventional study is to evaluate the efficacy of APG-157 in combination with Bevacizumab in subjects with recurrent high-grade glioma. The main questions the study aims to answer are:\n\n* Progression-free and overall survival of patients receiving this combination;\n* Quality of Life (QOL); and\n* Tumor response on imaging\n\nThe participants will take APG-157 daily by dissolving two pastilles in their mouth at around breakfast, lunch and dinner time (total of six pastilles per day). The pastilles dissolve in the mouth.\n\nThe participants will continue to receive Bevacizumab as standard of care.",[36,33],[635,636],"APG-157","Bevacizumab",{"date":572,"type":55},{"date":639,"type":55},"2023-12-13",{"date":641,"type":22},"2027-06-30",{"name":643,"class":125},"Aveta Biomics, Inc.",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":23,"phases":653,"briefSummary":655,"conditions":656,"keywords":660,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":670,"locationsCount":509},"100630364","phase-4-olutasidenib-ddi-study-in-patients-with-idh1-mutation-positive-malignancies-100630364","NCT07486713","Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies","A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib","Inclusion Criteria:\n\n* Adult male or female ≥ 18 years of age at the time of signing the informed consent form\n* Must have an Eastern Cooperative Oncology Group performance status ≤ 2.\n* Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy)\n* Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia \\[AML\\], gastrointestinal \\[GI\\] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.\n* Patient must have an adequate organ function, defined by the following:\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤ 2.5 × upper limit of normal (ULN).\n* Bilirubin ≤ 1.5× ULN (≤ 3 × ULN in patients with Gilbert Syndrome) or ≤ 3 × ULN for patients with AML involvement.\n* Creatinine clearance ≥ 30 mL\u002Fmin using Cockcroft-Gault equation.\n* Female patients who are women of childbearing potential (WOCBP) must have a negative serum (β-hCG) pregnancy test at screening and negative urine test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug. WOCBP are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.\n* WOCBP, must agree to use two methods of birth control (e.g. hormonal and a barrier method such as a condom), or must be considered highly unlikely to conceive during the dosing period and for 3 months after last study treatment.\n* Male patients with female partners of childbearing potential may be enrolled if they both agree to use highly effective methods of contraception during the dosing period and for 3 months after last study treatment.\n* Male patients must refrain from donating sperm during the dosing period and for 3 months after last study treatment.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breastfeeding.\n* Patients who are active smokers. Those who have ceased smoking \\> 1 month before the Screening Visit will be allowed.\n* Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.\n* Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.\n* Known allergy or history of hypersensitivity to study drugs or their excipients.\n* Human immunodeficiency virus (HIV) positivity.\n* Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or by RNA polymerase chain reaction (PCR) at screening.\n* Any patient's with a serious infection requiring intravenous or systemic antibiotics within 7 days prior to initiation of study treatment, or any active infection that, in the opinion of the Investigator, could impact patient's safety (e.g. COVID-19).\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug\n* Use of concomitant medications that are moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, and\u002For 3A4 inducers within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* History of or active, clinically significant, cardiovascular, respiratory, GI, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's opinion (or following review by the Sponsor), could affect the conduct of the study or the absorption, metabolism or excretion of the study treatment.\n* If less than the minimum time has elapsed from prior anticancer treatment to first dose of study treatment as follows:\n\n  1. Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin or antibody therapies, a minimum of 6 weeks.\n  2. Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent).\n* History of prior second malignancy unless disease-free for ≥ 12 months or considered surgically cured. Patients with nonmelanoma skin cancers or with carcinomas in situ at any time following curative intent surgery and low grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to the study, or previously resected are also eligible.\n* Patients with symptomatic central nervous system metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy.\n* Marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\> 480 milliseconds \\[msec\\]) (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 1) using Fridericia's QT correction formula.\n* Patients with New York Heart Association Class III or IV heart failure.",{"count":652,"type":22},16,[654],"PHASE4","A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.",[657,36,658,659],"AML (Acute Myeloid Leukemia)","Cholangiocarcinoma","Solid Tumor Malignancies",[661,662,663,664],"IDH1 Mutation","Hematology and Oncology","Oncology","Drug-Drug Interactions","2026-06-03",{"date":616,"type":55},{"date":668,"type":55},"2026-02-23",{"date":641,"type":22},{"name":671,"class":125},"Rigel Pharmaceuticals"]