[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-brain-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-brain-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,72],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100593184","phase-1-a-study-of-the-boron-neutron-capture-therapy-bnct-using-b10-l-bpa-in-malignant-brain-tumors-100593184",false,"NCT07003139","A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors","A Phase I\u002FII Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as Boron Carrier in Malignant Brain Tumors.","Inclusion Criteria:\n\n1. Age of 18 years and older.\n2. Patients with malignant brain tumors confirmed by histological and\u002For medical imaging, classified as WHO Grade 3 or 4 according to the World Health Organization of tumors of the central nervous system (CNS) classification, excluding those with histologically confirmed Grade 3 intracranial ependymoma, medulloblastoma, and primary CNS lymphoma.\n3. There must be a time interval ≥ 3 months between prior radiation therapy and the scheduled BNCT.\n4. There must be a time interval ≥ 1 month between receipt of antitumor drugs and the scheduled BNCT.\n5. Within 4 weeks prior to the screening visit, measurable disease by magnetic resonance imaging (MRI) and\u002For computed tomography (CT) scan showing a volume ≦ 250 cm\\^3, longest dimension \\\u003C 7 cm.\n6. At least one measurable lesion that can be assessed by RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 2.\n8. Life expectancy ≥ 3 months in the opinion of the investigator.\n9. Adequate organ functions as defined below:\n\n   * Hemoglobin ≥ 8.0 g\u002FdL.\n   * White blood cell (WBC) count ≥ 2.5 x 10\\^3\u002FμL.\n   * Neutrophil count ≥ 1.5 × 10\\^3\u002FμL.\n   * Platelet count ≥ 80 × 10\\^3\u002FμL.\n   * Aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN).\n   * Alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n   * Serum creatinine ≤ 1.5 × ULN\n   * Estimated glomerular filtration rate(eGFR) ≥ 15 mL \u002F min \u002F 1.73m\\^2\n10. Female subjects with reproductive potential must have a negative result of serum pregnancy test at the screening visit and urine pregnancy test before the B10 L-BPA administration. However, if the subject has been menopausal for at least 2 years (more than 24 months since the last menstrual period) or uses surgical birth control, testing is not required.\n11. Female subject with childbearing potential as well as male subject with reproductive potential must agree to refrain from unprotected sex and use 2 methods of highly effective contraception with their partner (e.g. barrier contraceptives \\[male condom, female condom, or diaphragm plus spermicide\\], intrauterine device, hormonal methods \\[hormone shot or injection, implants, combination oral contraceptives, or patches\\]) for ≥ 6 months after the BNCT until the end of this study.\n12. Physically and mentally capable of participating in the study and willing to adhere to study procedures.\n13. Provision of signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with malignant brain tumors complicated by any of the following conditions:\n\n   * Extracranial metastases.\n   * Multiple intracranial lesions on both sides.\n2. The investigator assesses that the subject has concurrent infections or other malignant tumors and is not suitable to participate in the trial.\n3. Patients with malignant brain tumors are considered eligible for standard surgical treatment that is effective against the tumor.\n4. A time interval less than 3 months from previous radiation therapy for intracranial region.\n5. A time interval less than 3 months from last brain surgery (excluding drainage procedures and biopsy) and less than 1 month from previous chemotherapy.\n6. The adverse event of previous anti-tumor therapy were NCI-CTCAE V5.0 grade evaluation ≧ Class 3 (excluding alopecia and peripheral neuropathy).\n7. Received or expect to receive any investigational drug, biologic or device within 1 month prior to the scheduled BNCT.\n8. Patients receiving or expected to receive vascular endothelial growth factor inhibitors (except bevacizumab) or live attenuated vaccines within 1 month prior to the scheduled BNCT.\n9. Patients received major surgery within 1 month prior to the scheduled BNCT or are still recovering from a previous surgery. The investigator will evaluate the subject's condition when the subject receives major surgery. Major surgery is defined as procedure that requires general anaesthesia and\u002For anticipated hospitalization longer than 24 hours, with significant risk of blood loss or complications. Examples include heart surgery, organ transplants, and prolonged operations such as certain back surgeries. Procedures such as stent implantation, biopsy, endoscopy, and day surgery are excluded.\n10. Patients who had radiation myelitits or radiation necrosis of the brain\u002Fbrain stem.\n11. Patient who is prone to vascular rupture during the trial as assessed by the investigator. The Patient will be eligible for the study if they have undergone stent implantation and obtained consent from the investigator.\n12. Patients with severe congestive heart failure or renal failure, as well as myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the scheduled BNCT.\n13. Severe comorbidities, including but not limited to poorly controlled epilepsy, poorly controlled diabetes mellitus, poorly controlled hypertension; chronic lung diseases (e.g., obstructive pneumonia, interstitial pneumonia, pulmonary fibrosis, and severe emphysema); kidney diseases (e.g., chronic renal failure, acute renal failure and nephrotic syndrome); cardiac diseases (e.g., New York Heart Association \\[NYHA\\] Functional Classification Class III or IV); phenylketonuria; and\u002For other severe conditions in the opinion of the investigator.\n14. Suspected or known hypersensitivity (including allergy) to boron or any component of the study drug or contrast media.\n15. Subject with hereditary fructose intolerance.\n16. With a cardiac pacemaker or will interfere with MRI-based or CT-based dose-planning or tumor response evaluation.\n17. Restless subjects who are unable to lie or sit in a cast for more than 30 minutes.\n18. Any medical or psychiatric conditions that, in the opinion of the investigator, may interfere with optimal participation in the study or place the subject at increased risk of adverse events (AEs).\n19. Female subject who is planning to be pregnant or lactating during the study period.\n20. Subject who is considered unfit to participate in the clinical study as assessed by the investigator.\n21. Subject who has received prior BNCT.","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This Phase I\u002FII study, titled 'A Phase I\u002FII Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) using B10 L-BPA as Boron Carrier in Malignant Brain Tumors.', aims to assess the efficacy of B10 L-BPA with BNCT in patients with malignant brain tumors. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for malignant brain tumors treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.",[27],"Malignant Brain Tumors",[29,30,31,27,32,33],"L-4-(10B)Boronophenylalanine","(10B)-4-Borono-L-phenylalanine","BNCT","Boron Neutron Capture Therapy","Borofalan (10B)","RECRUITING","2026-05-11",{"date":37,"type":38},"2026-05-13","ACTUAL",{"date":40,"type":38},"2025-06-30",{"date":42,"type":20},"2026-12",{"name":44,"class":45},"China Medical University Hospital","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100626686","phase-1-fluorescence-guided-imaging-of-brain-tumors-a-safety-study-using-sbk2-icg-100626686","NCT07438860","Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2-ICG","Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2- ICG in a Phase 1 Clinical Trial","Inclusion Criteria:\n\n* Participants must have suspected or confirmed untreated malignant brain tumors\n* Participants must have received no prior therapies for this disease.\n* Participants are 18 years of age or older. Because no dosing or adverse event data are currently available on the use of SBK2-ICG in individuals under 18 years of age, children are excluded from this study.\n* Karnofsky Performance status ≥ 60%\n* Glioma is located in the supratentorial region of the brain.\n* Tumor is suitable for resection on the basis of imaging studies and participant and surgeon must plan resection\n* Able and willing to undergo MRI scan.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Pregnant individuals or those who are breast feeding.\n* Individuals with AST, ALT, ALP, or bilirubin \\>2.5x normal upper limit any time during the previous 2 months.\n* Individuals with plasma creatinine \\> 2.5 mg\u002FdL.\n* Individuals without a probable or expected grade IV glioma.\n* Individuals not planning surgery on glioma.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG or other agents used in this study.\n* Note: A baseline blood sample will be drawn for creatinine, AST, ALT, ALP, and bilirubin to verify whether or not this exclusion criterion is met.",{"count":55,"type":20},12,[23],"Participants in this research study are people who are likely to have, or have been diagnosed with a brain tumor, for which surgical removal (or \"resection\") is the standard of care treatment. The purpose of this study is to see whether a drug called SBK2-ICG can be used to locate the true outline or \"edges\" of the tumor. If the tumor outline could be accurately identified at the time of surgery, the fullest extent of tumor could be removed while sparing the normal brain tissue.\n\nParticipants will receive SBK2-ICG about an hour before they receive surgery. The extent of surgery to be performed will not be changed in this study. Researchers will only use the information from the study to determine the best SBK2-ICG dose for accurate tumor margin (i.e., the border or edges of the tumor with the normal brain) detection so that no tumor is left behind.\n\nThe use of SBK2-ICG in brain tumors is experimental, which means that the U.S. Food and Drug Administration (FDA) has not approved it for use to locate brain tumors. However, the use of the drug SBK2-ICG for the purposes of this study is on file with the FDA.",[27,59],"Glioma",[61],"SBK2-ICG","NOT_YET_RECRUITING","2026-02-23",{"date":65,"type":38},"2026-02-27",{"date":67,"type":20},"2026-03-02",{"date":69,"type":20},"2026-12-31",{"name":71,"class":45},"Tiffany Hodges",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100605145","phase-1-phase-i-study-of-hsk42360-in-malignant-brain-tumors-with-braf-v600-mutation-100605145","NCT07158710","Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation","A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HSK42360 in Pediatric Patients With BRAF V600-Mutant Malignant Brain Tumors","Inclusion Criteria:\n\n1. Age ≥6 and \\\u003C18 years.\n2. Karnofsky\u002FLansky Performance Status \\>60.\n3. Life expectancy ≥ 3 months.\n4. Patients with recurrent malignant brain tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment); patients who have previously received BRAF and\u002For MEK inhibitor therapy are allowed to be included in this study.\n5. Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.\n6. Patients will provide blood or tumor sample according to their own willingness.\n7. Measurable disease by RANO criteria.\n8. Patients with inactive CNS lesions, or patients treated with ≤5mg\u002Fday corticosteroid and without convulsion for ≥2 weeks.\n9. Adequate hematologic, hepatic, and renal function.\n10. 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 for 90 days after the last dose.\n\nExclusion Criteria:\n\n1. Patients with NF1 mutation.\n2. malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.\n3. Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.\n4. Treatment with any of the following:\n\n   Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1\u002F2 prior to the first dose of HSK42360, whichever is shorter; Prior treatment with nitrosourea or mitomycin C within 6 weeks prior to the first dose of HSK42360; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK42360; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK42360.\n5. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.\n6. Any disease which would preclude drug absorption, metabolism or pharmacokinetics, eg. active peptic ulcer or chronic gastroesophageal reflux disease.\n7. Patient who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450 msec; any clinically significant arrhythmia; left ventricular ejection fraction \\\u003C 50%; myocardial infarction, unstable angina, or class III\u002FIV cardiac failure by the NYHA that occurred within 6 months prior to the first dose of HSK42360.\n8. Any thromboembolic events within 6 months prior to the first dose of HSK42360; any familial or aquired thrombophilia.\n9. Any unstable systemic disease, eg. severe metabolic disease: liver cirrhosis, renal failure, or uremia.\n10. Treatment with inhibitors\u002Finducers for CYP3A4, or substrates of CYP3A4, CYP2C9, CYP2C8, OATP1B1, OATP1B3, OAT1, OAT3, P-gp or BCRP within 14 days or approximately 5 × t1\u002F2 prior to the first dose of HSK42360, whichever is shorter.\n11. Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.\n12. Autologous transplantation surgery within 3 months prior to the first dose of HSK42360; Allogeneic transplantation, or stem-cell Transplant surgery within 6 months prior to the first dose of HSK42360; Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of HSK42360.\n13. Patient with a history of immunodeficiency, including HIV positive, or other acquired\u002Fcongenital immunodeficiency diseases.\n14. Patient with severe retinal abnormalities and uveitis.\n15. Patient with active hepatitis B or hepatitis C.\n16. Allergic to any HSK42360 active constituent or ingredients.\n17. Participate in other clinical trials within 4 weeks prior to the first dose of HSK42360.\n18. Positive pregnancy test, or breastfeeding.\n19. Any other circumstances that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.",{"count":80,"type":20},159,[23],"This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK of HSK42360 when given orally in pediatric patients with active BRAF V600 mutation recurrent malignant brain tumors.",[27],"2025-09-02",{"date":86,"type":38},"2025-09-08",{"date":88,"type":38},"2025-08-15",{"date":90,"type":20},"2029-12-03",{"name":92,"class":93},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",6]