[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"central-nervous-system-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:central-nervous-system-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":45},"100634419","phase-1-a-study-of-mirdametinib-in-people-with-central-nervous-system-tumors-100634419",false,"NCT07539441","A Study of Mirdametinib in People With Central Nervous System Tumors","Phase 1\u002F2 Trial of Mirdametinib in Patients With MAPK Pathway Mutant Central Nervous System Tumors","Inclusion criteria - Cohorts A and B\n\nDemographic Characteristics\n\na. Be \\> 18 years of age\n\nGeneral Criteria\n\n1. Have Karnofsky Performance Status (KPS) of ≥ 70% or ECOG Performance Status of ≤ 2\n2. Is able to understand and provide written informed consent for the trial prior to any study-specific procedures and is willing to comply with scheduled visits, treatment plans, procedures and laboratory tests. A legally authorized representative may consent on behalf of a subject who is otherwise unable to provide informed consent, if acceptable to and approved by the institutional review board.\n\nMedical and Therapeutic Criteria\n\n1. Have adequate bone marrow function, as determined by:\n\n   * Absolute neutrophil count (ANC) \\>1,500\u002Fmm3\n   * Platelet count \\>100,000 mm³\n   * Hemoglobin \\>9.0 mg\u002FdL\n2. Have adequate hepatic function, as determined by:\n\n   * Total bilirubin ≤1.5 x ULN if baseline was normal or ≤1.5 x baseline if baseline was abnormal. Patients with previously documented Gilbert's Syndrome may have total bilirubin ≤3 x ULN.\n   * AST and ALT ≤3.0 x ULN if baseline was normal or ≤3.0 x baseline if baseline was abnormal\n3. Have adequate renal function, as determined by:\n\n   o Creatinine clearance (CrCL) of ≥50 mL\u002Fmin by the Cockcroft-Gault formula\n\n   CrCl (mL\u002Fmin) = \\[140 - age (years)\\] x weight (kg) x 0.85 for female patients 72 creatinine (mg \u002F dL)\n4. Adequate cardiac function defined as follows\n\n   * Left ventricular ejection fraction \\>50% as assessed by multi-gated acquisition or ultrasound or echocardiography and\n   * Corrected QT interval (QTc) \\\u003C480 ms according to the Fridericia method (QTcF)\n5. Women of childbearing potential must have a negative serum pregnancy test before the start of therapy.\n6. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n7. Patients previously treated with radiotherapy must have recovered from acute toxicities associated with such treatment. Toxicities of investigational therapies should have recovered to grade 1 or less before start of the trial medication.\n\nAdditional cohort specific inclusion criteria - Neurohistiocytosis Cohort A\n\nSubjects must meet all of the following criteria to be enrolled in the Neurohistiocytosis cohort of this study:\n\n1. Have documented MAPK pathway mutation, or mutation not identified by tumor sequencing.: Patients with completed but negative tumor sequencing, or patients without sequencing performed but without safe disease sites for biopsy, are eligible for this study owing to the high likelihood of MAPK pathway mutation.\n2. Have documentation of disease: Patients must have a histologically confirmed histiocytic neoplasm or a constellation of histologic, radiologic, clinical, and\u002For molecular findings consistent with histiocytic neoplasm. This qualification is made because it is well known that biopsies of histiocytic neoplasms are variable and do not always demonstrate \"typical\" morphologic appearance with all of the classically described elements.\\[54\\] As a result, histiocytic neoplasms are not exclusively pathologic diagnoses-rather, they are interpretations of histologic findings in a clinical and radiologic context.\n3. Have measurable neurohistiocytic disease: Patients must have measurable radiologic or functional neurologic disease as defined by any of the following below. The presence of systemic disease is allowed however there must be at least one eligible manifestation of neurologic disease as defined below:\n\n   * Measurable disease according to modified PERCIST (mPERCIST) involving neurologic structures, i.e. meninges, brain or spinal cord parenchyma, or ocular structures (see sections below for these criteria) OR\n   * Measurable disease according to RECIST 1.1 involving neurologic structures OR\n   * Any of the below neurologic deficits referable to neurohistiocytosis amenable to longitudinal quantified assessment. The following are the allowable deficits, deemed referable to disease, with their corresponding assessments and minimum required abnormalities:\n\n     * Dysarthria as defined Speech Intelligibility of B or worse as measured by the Frenchay Dysarthria Scale\n     * Ataxia as defined by a score of 3 or higher on the Scale for assessment and rating of ataxia (SARA)\n     * Diplopia as defined by Prism Diopter of 5 or higher\n     * Loss of visual acuity defined as best corrected visual acuity (BCVA) 20\u002F40 (0.3 LogMAR) or worse in either eye\n     * Diminished visual field, defined as 20% or higher deficit in Humphrey Visual Field 24-2 pattern deviation.\n\nAdditional cohort specific inclusion criteria - Glioma Cohort B\n\nSubjects must meet all of the following criteria to be enrolled in the glioma cohort of this study:\n\n1. Have: somatic NF1 mutation as per next-generation sequencing (such as MSK Impact) --or- germline NF1 as per NIH clinical criteria\n2. Have a histologically confirmed glioma (per the 2021 WHO Classification of Tumors of the central nervous system)\n3. Have measurable, MRI-evaluable, unequivocal contrast enhancing disease as determined by radiologist on T1 post-contrast weighted images. Per RANO criteria, measurable lesion is defined as at least 1 enhancing lesion measuring \\> 1 cm x \\> 1 cm\n4. Have recurrent or progressive disease and received prior treatment with chemotherapy, radiation, or both\n5. Surgical resection is indicated for treatment, but surgery is not urgently indicated (e.g. for whom surgery within the next 4-6 weeks is appropriate)\n6. Have expected survival of \\> 3 months\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will not be enrolled in the study:\n\nGeneral criteria\n\n1. Is pregnant or nursing\n2. Is participating in another interventional study at the same time; participation in non-therapeutic registries is allowed\n\n   Medical and Therapeutic criteria\n3. Receipt of tumor directed therapy (chemotherapy, targeted therapy, biologic, investigational) within 28 days or 5 half-lives (whichever is shorter) before the first dose of mirdametinib.\n4. Concomitant use of medications that strongly induce CYP3A\n5. History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).\n6. Evidence of serious active infections. Patients are allowed to enroll if they have been fever free for at least 48 hours\n7. Uncontrolled or severe intercurrent medical condition\n8. Have significant active cardiac disease within 6 months before the start of treatment, including New York Heart Association Class III or IV congestive heart failure, atrial fibrillation, myocardial infarction, unstable angina and\u002For stroke.\n9. Have significant active ophthalmologic disease within 6 months before the start of treatment, including central retinal vein occlusion\n10. Has a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator\n11. Cohort A only: Patients with documented driver mutations outside of the MAPK pathway are not eligible for this study. These are uncommon and include mutations in ALK, RET, CSF1R, NTRK, and other kinases20 .\n\nOn Study Guidelines:\n\nPhysicians should consider the following when evaluating if the patient is appropriate for this study:\n\n* Cohorts A and B: Patients with cytopenias, renal impairment or hepatic impairment deemed the direct result of disease and therefore amenable to improvement with mirdametinib treatment may be enrolled at the discretion of the treating investigator\n* Cohort A: There is no prior therapy requirement given the poor CNS efficacy of standard therapies, morbidity of neurohistiocytosis, and the available data about safety and efficacy in nine patients treated with mirdametinib.\n* The effects of mirdametinib on the developing human fetus are unknown. For this reason, female participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 weeks following the completion of study therapy. Male participants with female partners of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 3 months following the completion of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.","ALL","18 Years",{"count":19,"type":20},26,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study to find out whether mirdametinib is a safe and effective treatment for Central Nervous System\u002FCNS tumors (glioma and neurohistiocytosis).",[27,28],"Central Nervous System Tumors","Glioma",[27,28,30,31,32,33],"Neurohistiocytosis","Mirdametinib","Memorial Sloan Kettering Cancer Center","26-103","RECRUITING","2026-05-12",{"date":37,"type":38},"2026-05-13","ACTUAL",{"date":40,"type":38},"2026-04-10",{"date":42,"type":20},"2029-10-10",{"name":32,"class":44},"OTHER",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100457321","phase-1-oh2-oncolytic-viral-therapy-in-central-nervous-system-tumors-100457321","NCT05235074","OH2 Oncolytic Viral Therapy in Central Nervous System Tumors","A Clinical Study of Oncolytic Virus (OH2) Injection in the Treatment of Patients Undergoing Surgery After Recurrence of Central Nervous System Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years old, male or female;\n2. Phase I trials select pathologically confirmed recurrent central nervous system tumors (including but not limited to anaplastic astrocytoma, anaplastic oligoastrocytoma, glioblastoma, gliosarcoma, anaplastic ependymoma, Medulloblastoma, malignant meningioma, melanoma, etc.) postoperative patients; Phase IIa trial selects postoperative patients with pathologically confirmed recurrent glioblastoma\n3. KPS score ≥60;\n4. Partial or complete tumor resection, Ommaya reservoir has been placed in the operation area, and drug administration conditions are available;\n5. As assessed by the investigator, the site of injection of the trial drug is expected to be in the supratentorial area;\n6. Life expectancy ≥3 months;\n7. Blood routine: WBC≥ 3.0×10\\^9\u002FL, ANC≥1.5×10\\^9\u002FL, PLT≥100×10\\^9\u002FL, Hb≥9.0 g\u002FdL;\n8. Liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of the normal value; AST and ALT \\\u003C 2.5 times the upper limit of the normal value; serum creatinine ≤1.5 times the upper limit of the normal value, or creatinine clearance ≥50 ml\u002Fmin (calculated by Cockcroft\u002FGault formula);\n9. Coagulation function: INR≤1.5 times the upper limit of the normal value, APTT≤1.5 times the upper limit of the normal value;\n10. Women of childbearing age had a negative pregnancy test result within 14 days before enrollment. Female subjects and their spouses received effective contraceptives during and within 6 months of treatment;\n11. The subjects voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1.28 days before enrollment, subjects participated in other clinical trial projects.\n\n2.The subject has received tumor chemotherapy, targeted therapy or immunotherapy within 28 days before the first use of the test drug.\n\n3.The subjects have received traditional Chinese medicine, modern Chinese medicine preparations and antiviral drugs within 7 days before using the test drug for the first time.\n\n4.Subjects had received radiotherapy to the brain 3 months before their first use of the test drug.\n\n5.Subjects with other active extracranial malignancies requiring concomitant therapy.\n\n6.Subjects known to be allergic to the test drug or its active ingredients, excipients, and imaging contrast agents.\n\n7.Subjects who are going to undergo or have received tissue\u002Forgan transplantation in the past.\n\n8.The subject has active infection or unexplained fever \\>38.5℃ during the screening period and before the first dose.\n\n9.Subjects with active pulmonary tuberculosis (TB) who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before screening.\n\n10.Anti-HIV(+) or anti-HCV(+) or specific antibody (TPHA) positive or active hepatitis B (hepatitis B subjects who meet the following criteria are also eligible for inclusion: a) HBV viral load before the first dose The amount must be less than 1000 copies\u002Fml (200 IU\u002Fml), and subjects should receive anti-HBV treatment throughout the trial drug treatment period to avoid viral reactivation; b) For anti-HBc (+), HBsAg (-), anti-HBs ( -) and viral load (-) subjects, do not require prophylactic anti-HBV therapy, but require close monitoring for viral reactivation.\n\n11.Cardiovascular disease meets any of the following: a. Congestive heart failure with cardiac function ≥ NYHA class III; b. Serious arrhythmia requiring drug treatment; c. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass, or stenting occurred within 6 months before the first administration; d. Left ventricular ejection fraction (EF) \\\u003C 60%; e. QTcF interval \\> 450 ms in men, \\> 470 ms in women, or risk factors for torsades de pointes such as clinically significant hypokalemia, family history of long QT syndrome, or family history as judged by the investigator History of arrhythmias (eg, pre-excitation syndrome); f. Uncontrolled hypertension (defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg after standardized antihypertensive drug treatment).\n\n12.Subjects with active autoimmune disease or a history of autoimmune disease but may relapse, but subjects with the following diseases are not excluded and can be further screened: a. Type 1 diabetes; b. Hypothyroidism (if controllable with hormone replacement therapy alone); c. controlled celiac disease; d. Skin diseases that do not require systemic treatment (eg vitiligo, psoriasis, alopecia); e. Any other disease that will not recur in the absence of external triggers.\n\n13.Subjects with unstable mental illness, alcohol, drug or substance abuse. 14. Female subjects who are pregnant or breastfeeding, or who are expected to become pregnant during the trial period (from the screening visit until 180 days after dosing) and male subjects who are expected to conceive their partner.\n\n15\\. The adverse reactions of previous anti-tumor therapy have not recovered to (CTCAE 5.0) grade 1 (except for alopecia).\n\n16\\. The investigator determines that he has a serious uncontrollable disease, or there are other conditions that may affect the acceptance of the treatment in this study, and are considered unsuitable to participate in this researcher.\n\n17\\. Other investigators deem it unsuitable for enrollment.",{"count":54,"type":20},28,[23,24],"In the first phase, it mainly explores the safety, tolerability and preliminary effectiveness of two doses of OH2 injection in the treatment of patients with recurrent central nervous system tumors; to evaluate the biodistribution and virus shedding of OH2 injection administered in the tumor cavity; to evaluate the level of anti-HSV2 antibody in patients when OH2 injection is administered intracavitary to tumor; to determine the phase II recommended dose (RP2D) of OH2 injection in the treatment of recurrent glioblastoma.\n\nPhase IIa, to evaluate the preliminary efficacy of OH2 injection in the treatment of patients with recurrent glioblastoma after surgery, and to further evaluate the safety of OH2 in the treatment of relapsed glioblastoma.",[27],[59],"Oncolytic Virus","2025-07-22",{"date":62,"type":38},"2025-07-25",{"date":64,"type":38},"2021-11-16",{"date":66,"type":20},"2026-06-16",{"name":68,"class":69},"Binhui Biopharmaceutical Co., Ltd.","INDUSTRY",1]