[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-multiforme-gbm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-multiforme-gbm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,60,92,123,154,178,200,236,261,292,314,338,364],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100618049","phase-2-study-of-silevertinib-with-temozolomide-for-the-treatment-of-newly-diagnosed-gbm-with-unmethylated-mgmt-and-egfrviii-100618049",false,"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.","ALL","18 Years",{"count":19,"type":20},162,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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?",[26,27,28,29,30,31,32],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma","GBM","Glioblastoma Multiforme (GBM)","Glioma","Central Nervous System Diseases","Brain Cancer",[34,35,36,37,38,39,40,41,42,43,44,45,46],"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)","RECRUITING","2026-06-18",{"date":50,"type":51},"2026-06-22","ACTUAL",{"date":53,"type":51},"2026-05-05",{"date":55,"type":20},"2029-03",{"name":57,"class":58},"Black Diamond Therapeutics, Inc.","INDUSTRY",14,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100302121","phase-1-oral-capecitabine-and-temozolomide-captem-for-newly-diagnosed-gbm-100302121","NCT03213002","Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM","Phase I\u002FII Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)","CAPTEM","Inclusion Criteria:\n\n1. Be capable of giving informed consent.\n2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV\n3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide\n4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential\n5. Have a life expectancy \\> 3 months\n6. Be between the ages of 18 to 74\n7. Have a performance status KPS 70 or greater\n8. Be able to swallow pills and capsules\n9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings\n10. Have adequate bone marrow function, liver function and renal function before commencing therapy\n\nExclusion Criteria:\n\n1. Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.\n2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.\n3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),\n4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)\n5. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).\n6. Performance status, KPS \\\u003C 70\n7. Inability to swallow pills and capsules\n8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy\n9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine\n10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance\n11. Patients with renal insufficiency or hepatic insufficiency\n12. Patients with coagulopathies\n13. Women who are pregnant or lactating.","74 Years",{"count":70,"type":20},67,[72,23],"PHASE1","The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).\n\nCapecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg\u002Fm2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.",[29,35,75,76,77,78,79,80,32],"Glioma of Brain","Glioblastoma, Adult","Brain Tumor","Brain Tumor, Primary","Brain Tumor Adult","Cancer","2026-05-28",{"date":83,"type":51},"2026-06-01",{"date":85,"type":51},"2017-06-13",{"date":87,"type":20},"2029-06",{"name":89,"class":90},"Northwell Health","OTHER",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100635403","nk-cell-therapy-for-malignant-solid-brain-tumors-100635403","NCT07552233","NK Cell Therapy for Malignant Solid Brain Tumors","NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors","Inclusion Criteria:\n\n1. Male or female, age 18-70 years old (both ends included)\n2. At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment\n3. Karnofsky Performance Status (KPS) ≥ 60%\n4. Life expectancy \\> 4 weeks, and must be able to undergo an MRI with contrast\n5. Patients who completed radiotherapy or systemic therapies (including temozolomide\u002Fbevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)\n6. Dexamethasone dose ≤ 4 mg\u002Fday or equivalent corticosteroid dose, or no dexamethasone administered\n7. Must have adequate organ and marrow function as defined below:\n\n   * White blood cell count (WBC) ≥ 3 x 10\\^9\u002FL\n   * Absolute neutrophil count (ANC) \\> 1 x 10\\^9\u002FL\n   * Hemoglobin (Hb) ≥ 90 g\u002FL\n   * Platelet (PLT) ≥ 80×10\\^9\u002FL\n   * Albumin transaminase (ALT) \\& albumin transaminase (AST) \\\u003C 1.5 × institutional upper limit of normal (ULN)\n   * Serum creatinine (Cr) \\\u003C 1.5 x institutional ULN\n   * Total bilirubin \\\u003C 1.5 x institutional ULN\n   * PT \\& PTT ≤ 1.25 x institutional ULN\n8. No obvious hereditary diseases\n9. Normal cardiac function with left ventricular ejection fraction \\>55%\n10. No bleeding and coagulation disorders\n11. Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and\u002For there aren't any indications of meningitis\n12. Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately\n13. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Active hepatitis B or C virus, HIV infection, or other untreated active infection\n2. Pregnant and lactating women\n3. Participants with organ failure\n4. Participants with a chronic disease requiring immunologic or hormonal therapy\n5. Participants with an allergy to immunotherapy and related cells\n6. Participants with uncontrolled intercurrent illness\n7. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n8. Participants with a history of organ transplantation or who are awaiting organ transplantation","70 Years",{"count":101,"type":20},27,[103],"NA","This is a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy. Secondary objectives include preliminary assessment of anti-tumor activity as measured by progression-free survival (PFS), overall survival (OS), objective response rate (ORR) per RANO criteria, and evaluation of the immunological effects of NK cell infusion in the tumor microenvironment and peripheral blood.",[106,26,29,107,108],"Malignant Solid Brain Tumors","Brain Metastasis","Malignant Meningioma",[106,110,111,112],"Immunotherapy","Natural Killer Cell","NK Cell","2026-04-20",{"date":115,"type":51},"2026-04-27",{"date":117,"type":20},"2026-04",{"date":119,"type":20},"2030-12-31",{"name":121,"class":90},"Peking University Third Hospital",4,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":142,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100587260","phase-1-early-phase-study-of-kesonotidein-participants-with-solid-tumours-100587260","NCT06926075","Early Phase Study of KESONOTIDE™in Participants With Solid Tumours","An Adaptive Phase I\u002FII Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours","ADVICE","Inclusion Criteria:\n\n* Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).\n* Has an ECOG performance status score of 0 or 1.\n* Has a life expectancy of \\> 12 weeks in the opinion of the investigator.\n* Measurable or evaluable disease by CT\u002FMRI according to RECIST v1.1, except for prostate and breast cancer (bone only metastases are acceptable) and glioma.\n* Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid cancers.\n* Has adequate organ function within 7 days prior to Day 1 of Cycle 1, defined as below:\n* Laboratory Value\n* Hematology\n* Platelet count \\> 100 x 109\u002FL\n* Hb \\> 9.0 g\u002FdL\n* ANC \\> 1.5 x 109\u002FL\n* Renal Function\n* Creatinine \\\u003C 1.5 x ULN\n* Hepatic Function\n* AST and ALT \\\u003C 3 x ULN for the reference laboratory or \\\u003C 5 x ULN in the presence of liver metastases\n* Total bilirubin ≤ 1.5 x ULN\n* Serum albumin ≥ 2.5 g\u002FdL\n* INR\u002FPT and APTT ≤ 1.5 x ULN\n* Male and female participants of reproductive\u002Fchildbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) for at least 90 days during the study and after the last dose of study drug.\n* Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 90 days after the final study drug administration.\n* Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and at least 90 days after the final study drug administration.\n* Has failed standard of care or refused next line therapy at the present time and if approved treatment options are still available, can delay approved treatments without harm as judged by the investigator (e.g., patients requesting a break between lines of therapy).\n\nAdditional Inclusion Criteria for Parts 2 and 3:\n\n* Measurable disease (as defined for Part 1) or recognised and abnormal biomarker levels (e.g., PSA for prostate cancer, CA15.3 for breast cancer).\n* Defined diseases or disease states of interest, suitable for dose expansion.\n* Patients who have enrolled in Part 1 of the study (dose-escalation), and in the opinion of the investigator, are benefitting from treatment, may be eligible for Parts 2 and 3.\n\nExclusion Criteria:\n\n* Participants who are unable to cease any anti-inflammatory medications or statins prior to and during the study, including non-steroidal anti-inflammatories, oral steroids at any dose; topical steroids and anti-inflammatories are allowable.\n* Participants who have participated in other clinical trials and received investigational products within 4 weeks, or within five half-lives of the treatment, whichever is longer, before Cycle 1 Day 1 of the study period.\n* Previous adverse reactions which have not returned to Grade 0 or 1 according to NCI-CTCAE v5.0 (except alopecia and fatigue) at the screening visit.\n* A clinically significant active infection determined by the investigator.\n* Significant or recurrent third space accumulation (e.g., ascites or pleural effusions) according to the investigator.\n* Has a medical history of myocardial infraction or unstable angina within 6 months before enrolment.\n* Has a medical history of symptomatic CHF (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment.\n* Has a history or presence of uncontrolled mental illness.\n* The participant is expected to be non-compliant with critical trial procedures and is not willing or able to adhere to the trial requirements during the study.\n* Participants are deemed inappropriate for this clinical trial at the discretion of the investigator.\n\nAdditional Exclusion Criteria for Parts 2 and 3:\n\n\\- Patients must not have more than 2 prior lines of therapy.",{"count":132,"type":20},80,[72,23],"This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers.\n\nIt is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II.\n\nPrimary objective is to evaluate safety and tolerability of KESONOTIDE™ as a monotherapy in participants with advanced\u002Fmetastatic solid cancers.\n\nSecondary objective is to characterise the pharmacokinetics of KESONOTIDE™. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.",[136,137,138,139,29,140,141],"Prostate Cancers","Breast Cancer","Lung Cancers","Ovarian Cancer","Pancreas Cancer","Skin Cancer",[143],"kesonotide, vimentin inhibotor","2026-03-15",{"date":146,"type":51},"2026-03-17",{"date":148,"type":51},"2025-11-07",{"date":150,"type":20},"2027-10-26",{"name":152,"class":58},"Filamon LTD",3,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":91},"100623021","phase-1-5g-pearl-paxalisib-in-malignant-brain-tumours-100623021","NCT07391215","5G-PEARL: Paxalisib in Malignant Brain Tumours","5G-PEARL: Paxalisib in Combination With Temozolomide in Patients With High Grade Malignant Brain Tumours Within the 5G Platform","5G-PEARL","Inclusion Criteria:\n\nPhase 1b front line mrd cohort:\n\n1. Patients with histologically confirmed advanced WHO Stage IV glioblastoma (per fourth edition 2016). Per the new 2021 fifth edition of WHO Classification of Tumours of the Central Nervous System, this will include:\n\n   • Glioblastoma, IDH-wildtype Grade 4\n2. Patients for Phase 1b will need to have consented to the Minderoo Precision Brain Tumour Programme and have whole genome, and transcriptome data available. Patients who have had NHS funded whole genome sequencing and have available frozen tissue stored can be recruited to the study in parallel to consenting to the Minderoo Precision Brain Tumour Programme to have transcriptome analysis done.\n3. Patients for the minimal residual disease (mrd) cohort will be eligible following completion of optimal surgery and Stupp based adjuvant chemoradiotherapy as long as they meet all other inclusion\u002Fexclusion criteria. Patients will need to commence Cycle 1 Day 1 of the study no later than 6 weeks from the completion of chemoradiotherapy. Patients who are radiologically progressing following chemo-radiotherapy will not be eligible.\n4. 16 years or over.\n5. Life expectancy of at least 12 weeks.\n6. World Health Organisation (WHO) performance status of 0-1.\n7. Neurologically stable (eg without a progression of neurological symptoms or requiring escalating doses of systemic steroid therapy within one week prior to cycle 1, day 1.\n8. Written (signed or dated) informed consent and be capable of co-operating with treatment and follow up.\n9. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP.\n\n   Haemoglobin (Hb): ≥ 9.0 g\u002FdL Absolute neutrophil count: ≥1.5 x 10\\^9\u002FL Platelet count: ≥100 x 10\\^9\u002FL Coagulation: INR \\\u003C 1.5 and APTT \\\u003C1.5x if not anticoagulated INR stable \\> 7 days within intended therapeutic range if anticoagulated Bilirubin: ≤1.5 x ULN; participants with Gilbert's syndrome can enrol if conjugated bilirubin is within normal ranges.\n\n   Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): \\\u003C3 x ULN Albumin: ≥ 28 g\u002FL Creatinine: \\\u003C1.5 x ULN Sodium: ≥130 mmol\u002FL Potassium, Calcium, Magnesium, phosphate: Within institution normal ranges (replacement is permitted) HbA1C (%): \\\u003C8.0 Urinary protein: \\\u003C 1+ on dipstick\n10. Female patients with reproductive potential must have a negative serum pregnancy test within 14 days prior to start of trial.\n11. Men and women of childbearing potential must agree to comply with the use of a highly effective method of contraception so as to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 180 days after the last dose of either investigational drug. Please, refer to section 4.1 of the Clinical Trials Facilitation and Coordination Group (CTCG) guidance for further details.\n\nExclusion Criteria:\n\nPhase 1b frontline mrd cohort:\n\n1. Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:\n\n   * Bevacizumab during the prior 6 weeks\n   * Any investigational medicinal product since diagnosis.\n   * Tumour treating fields during the prior 6 weeks\n2. Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted. Prior use of any other immune-modulatory investigational agent must be discussed with sponsor team and CI.\n3. Ongoing Grade 2 or greater toxicities from pre-existing conditions or from previous treatments.\n4. Patients with carcinomatous meningitis, leptomeningeal spread of tumour, spread of tumour to the brain stem or spinal cord.\n5. Has evidence of recent intratumoural or peritumoural haemorrhage on baseline MRI. Patients with radiological findings that are stable on at least 2 consecutive MRI scans at least 3 weeks apart will be eligible.\n6. History of clinical relevant bleeding disorders, including significant GI bleeding within last 6 months.\n7. History of arterial thromboembolism.\n8. Recent (within 3 months) deep vein thrombosis or pulmonary embolism or other significant thromboembolism. Venous port of catheter thrombosis or superficial thrombosis are not considered significant. Patients with prior thrombosis (\\> 3 months ago) on stable anticoagulation are permitted to be enrolled.\n9. History of clinically significant cardiac disorders:\n\n   * Myocardial infarction, or New York Heart Association Class II to IV congestive heart failure, within 6 months of the first dose of study drug.\n   * Concurrent and clinically significant abnormalities on electrocardiogram (ECG) at Screening, including a corrected QT interval (QTcF \\>480ms).\n10. History of malabsorption syndrome or other conditions that may interfere with enteral absorption. Patients with a history of or active inflammatory bowel disease (eg Crohn's disease or ulcerative colitis). History of gastrointestinal perforation or fistulae.\n11. History of uncontrolled diabetes. Patients with controlled diabetes on therapy with HbA1C \\\u003C8% will be eligible.\n12. Has urine protein \\> 1g\u002F24 hours. Participants with \\>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n13. Has significant lung disease including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active tuberculosis, or history of opportunistic infections (including PCP or CMV pneumonia).\n14. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n15. Steroid requirement for neurological symptom control of \\>3mg Dexamethasone per day (patients will allowed to enrol if they have been on a stable dose of steroids of equivalent or less than 3mg Dexamethasone for at least 5 days prior to Day 1 of Cycle 1).\n16. Has received a live vaccine within 30 days of planned start of study therapy. Note: inactive vaccines including COVID vaccines are allowed prior to 1 week of Day 1 of Cycle 1).\n17. Current active concurrent malignancy. Cancer survivors who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease recurrence for three years or more and are deemed at negligible risk of recurrence will be eligible.\n18. Is a participant or plans to participate on another interventional clinical trial while taking part in this Phase 1 study. Participation in an observational trial would be acceptable.\n19. Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.\n20. Exposure to medications (with or without prescriptions), supplements, herbal remedies, or foods with potential for drug-drug interactions with study interventions within 14 days prior to the first dose of study intervention and during the course of therapy, including strong CYP3A4 inhibitors or inducers, due to potential drug-drug interactions with both paxalisib and temozolomide.\n21. Major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks.\n22. Live and attenuated vaccines are not permitted during or within 4 weeks prior to initiation of study treatment.\n\nInclusion and Exclusion criteria for Phase 2:\n\n1. This will be broadened following an assessment of the safety and tolerability seen in the Phase 1 to be more inclusive and reflective of the real-world population.\n2. Patients with any other CNS tumours will only be eligible for defined Phase 2 biomarker arms once a Phase 1b GO decision has been met. Specific eligibility criteria for these tumours will be defined following an amendment.","16 Years",{"count":164,"type":20},64,[72,23],"The purpose of this clinical trial is to evaluate the safety and tolerability of paxalisib in combination with temozolomide and to determine the preliminary antitumour activity of the combination therapy. In the Phase 1b of this study parallel biomarker defined arms will be opened in the front-line unmethylated MGMT setting, enrolling 10 patients onto each arm. These patients will be treated with paxalisib in combination with temozolomide (TMZ). The starting dose of paxalisib will be 45mg once a day (OD) with the option of increasing to 60 mg (30 mg BD) in Cycle 2. TMZ will be administered once daily by mouth on days 1 to 5 in a 28-day cycle, with a starting dose of 150mg\u002Fm2 during cycles 1 and 2, and subsequent dose escalation to 200mg\u002Fm2 at the start of cycle 3 if cycles 1 and 2 have been well tolerated with no significant toxicity.",[168,29],"Malignant Primary Gliomas","2026-01-29",{"date":171,"type":51},"2026-02-05",{"date":173,"type":20},"2026-01-19",{"date":175,"type":20},"2029-06-30",{"name":177,"class":90},"Institute of Cancer Research, United Kingdom",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":162,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":153},"100564521","phase-1-5g-ruby-avutometinib-and-defactinib-in-malignant-brain-tumours-100564521","NCT06630260","5G-RUBY: Avutometinib and Defactinib in Malignant Brain Tumours","A Phase 1\u002F2 Trial of the Doublet Combination of Avutometinib and Defactinib and as a Triplet in Combination With Temozolomide in Patients With High Grade Malignant Brain Tumours Within the 5G Platform","5G-RUBY","Inclusion Criteria for Phase 1b:\n\n1. Patients with histologically confirmed advanced WHO Stage IV glioblastoma (per fourth edition 2016). Per the new 2021 fifth edition of WHO Classification of Tumours of the Central Nervous System, this will include:\n\n   * Glioblastoma, IDH-wildtype Grade 4\n   * Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2\u002F3 are not included)\n   * Diffuse hemispheric glioma, H3 G34 mutant Grade 4\n\n   Patients with any other CNS tumours will only be eligible for defined Phase 2 biomarker arms once a Phase 1b GO decision has been met. Specific eligibility criteria for these tumours will be defined following an amendment.\n2. Patients for Phase 1 will need to have consented to the Minderoo Precision Brain Tumour Programme and have available whole genome, and transcriptome data available.\n3. Patients for the relapsed cohorts will be eligible at first relapse following completion of optimal surgery, and Stupp based adjuvant chemo-radiotherapy (or equivalent). They will need to have measurable disease per RANO or evaluable disease.\n4. Patients for the front line minimal residual disease (mrd) cohort will be eligible following completion of optimal surgery and Stupp based adjuvant chemoradiotherapy as long as they meet all other inclusion\u002Fexclusion criteria.\n5. 16 years or over\n6. Life expectancy of at least 12 weeks.\n7. World Health Organisation (WHO) performance status of 0-1\n8. Neurologically stable (e.g., without a progression of neurological symptoms or requiring escalating doses of systemic steroid therapy within the last week)\n9. Written (signed or dated) informed consent and be capable of co-operating with treatment and follow up\n10. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP\n\n    Haemoglobin (Hb): ≥ 9.0 g\u002FdL; Absolute neutrophil count: ≥1.5 x 10\\^9\u002FL; Platelet count: ≥100 x 10\\^9\u002FL; Coagulation: INR \\\u003C1.5 and APTT \\\u003C1.5x if not anticoagulated, INR stable \\> 7 days within intended therapeutic range if anticoagulated; Bilirubin: Within institution normal ranges; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): \\\u003C3 x ULN; Albumin: ≥ 28 g\u002FdL; Creatinine: \\\u003C1.5 x ULN; Sodium: ≥130 mmol\u002FL; Potassium, Calcium, Magnesium, phosphate: Within institution normal ranges (replacement is permitted); Urinary protein: \\\u003C 1+ on dipstick.\n11. Female patients with reproductive potential must have a negative serum pregnancy test within 14 days prior to start of trial.\n12. Men and women of childbearing potential must agree to comply with the use of a highly effective method of contraception to avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 150 days after the last dose of either investigational drug.\n\nExclusion Criteria for Phase 1b:\n\n1. Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:\n\n   * Cytotoxic chemotherapy during the prior 2 weeks or 6 weeks for nitrosoureas\n   * Bevacizumab during the prior 6 weeks\n   * Five half-lives of any small molecule investigational or licensed medicinal product.\n2. Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted. Prior use of any other immune-modulatory investigational agent must be discussed with sponsor team and CI. Prior use of BRAF or MEK inhibitors is not permitted.\n3. Ongoing Grade 2 or greater toxicities from pre-existing conditions or from previous treatments.\n4. Patients with carcinomatous meningitis, leptomeningeal spread of tumour, spread of tumour to the brain stem or spinal cord.\n5. Has evidence of recent intratumoural or peritumoural haemorrhage on baseline MRI. Patients with radiological findings that are stable on at least 2 consecutive MRI scans at least 3 weeks apart will be eligible.\n6. History of clinically relevant bleeding disorders, including significant GI bleeding within last 6 months.\n7. History of arterial thromboembolism.\n8. Recent (within 3 months) deep vein thrombosis or pulmonary embolism or another significant thromboembolism. Venous port of catheter thrombosis or superficial thrombosis are not considered significant. Patients with prior thrombosis (\\> 3 months ago) on stable anticoagulation are permitted to be enrolled. Patients on Warfarin will need to be converted onto low-molecular weight-based heparin therapy.\n9. History of clinically significant cardiac disorders:\n\n   * Myocardial infarction, or New York Heart Association Class II to IV congestive heart failure, within 6 months of the first dose of study drug\n   * Concurrent and clinically significant abnormalities on ECG at Screening, including a corrected QT interval (QTcF \\>460ms).\n10. History of malabsorption syndrome or other conditions that may interfere with enteral absorption. Patients with a history of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). Patients with acute or chronic pancreatitis. History of gastrointestinal perforation or fistulae. Patients with known Gilbert's syndrome will be excluded from this study.\n11. Concurrent ocular disorders:\n\n    1. Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes\n    2. Patient with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n    3. Patients with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions.\n12. Has urine protein \\> 1g\u002F24 hours. Participants with \\>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n13. Has significant lung disease including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active tuberculosis, or history of opportunistic infections (including PCP or CMV pneumonia).\n14. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n15. Steroid requirement for neurological symptom control of \\> 3mg Dexamethasone per day (patients will allowed to enrol if they have been on a stable dose of steroids of equivalent or less than 3mg Dexamethasone for at least 5 days prior to Day 1 of Cycle 1).\n16. Has received a live vaccine within 30 days of planned start of study therapy. Note: inactive vaccines including COVID vaccines are allowed prior to 1 week of Day 1 of Cycle 1).\n17. Current active concurrent malignancy. Cancer survivors who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease recurrence for three years or more and are deemed at negligible risk of recurrence will be eligible.\n18. Is a participant or plans to participate on another interventional clinical trial while taking part in this Phase 1 study. Participation in an observational trial would be acceptable.\n19. Exposure to medications (with or without prescriptions), supplements, herbal remedies, or foods with potential for drug-drug interactions with study interventions within 14 days prior to the first dose of study intervention and during the course of therapy, including:\n\n    1. Strong CYP3A4 inhibitors or inducers, due to potential drug-drug interactions with both avutometinib and defactinib.\n    2. Strong CYP2C9 inhibitors or inducers, due to potential drug-drug interactions with defactinib. Not applicable if and when patients randomized to avutometinib monotherapy.\n    3. Strong P-glycoprotein (P-gp) inhibitors or inducers, due to potential drug-drug interactions with both avutometinib and defactinib.\n    4. Strong breast cancer resistance protein (BCRP) inhibitors or inducers, due to potential drug-drug interactions with avutometinib.\n20. Major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 1 week of the first dose of defactinib.\n21. Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.",{"count":187,"type":20},182,[72,23],"The purpose of this clinical trial is to evaluate the safety and tolerability of avutometinib and defactinib and to determine the preliminary antitumour activity of avutometinib and defactinib administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study parallel biomarker defined arms will be opened, initially in the relapsed GMB setting, enrolling 12 patients onto each arm. These patients will be treated with avutometinib and defactinib double therapy. Avutometinib will be administered orally at 3.2mg twice a week (e.g., on Monday \u002F Thursday or Tuesday \u002F Friday) with or without a meal. The total weekly dose of avutometinib is 6.4mg. Defactinib will be administered orally, at 200mg, twice a day within 30 min after a meal. The total daily dose of defactinib is 400mg.\n\nOnce a treatment in any biomarker arm has met the \"GO\" decision (≥3 successes\u002F12 patients) for relapsed GBM in Phase 1b, that arm can progress to Phase 2. The primary objective of Phase 2 is to determine the antitumour activity of investigational agents administered at the RP2D in patients with molecularly defined malignant brain tumours.",[29,191,192,168],"Glioblastoma Multiform (Grade IV Astrocytoma)","Diffuse Hemispheric Glioma, H3 G34-Mutant",{"date":194,"type":51},"2026-01-21",{"date":196,"type":51},"2024-11-15",{"date":198,"type":20},"2030-09-30",{"name":177,"class":90},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":210,"briefSummary":211,"conditions":212,"keywords":216,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":91},"100606728","phase-1-focused-ultrasound-blood-brain-barrier-disruption-for-the-treatment-of-high-grade-glioma-in-patients-undergoing-standard-chemotherapy-100606728","NCT07179328","Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy","Assessment of Safety and Feasibility of Focused Ultrasound Next Generational Dome Helmet Mediated Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy","Inclusion Criteria:\n\n1. Age between 18 and 85 years, inclusive.\n2. Able and willing to provide written informed consent.\n3. Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification.\n4. Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without any complications and deemed eligible for the maintenance phase of TMZ treatment.\n5. Tumor or tumor resection cavity is clearly defined on screening MRI scans.\n6. Karnofsky Performance Score rating 70-100.\n7. American Society of Anesthesiologists (ASA) physical status score of 1-3.\n8. Life expectancy of at least 3 months and able to attend all study visits.\n\nExclusion Criteria:\n\n1. Patients presenting with the following imaging characteristics:\n\n   i. Following steroid treatment, brain edema and\u002For mass effect that causes midline shift or shift in wall of the third ventricle of more than 10 mm.\n\n   ii. Evidence of recent (less than 2 weeks) intracranial hemorrhage. iii. Calcifications in the FUS sonication beam path in the event system tools cannot tailor the treatment around these calcification spots.\n2. The sonication pathway to the tumor involves:\n\n   i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.\n\n   ii. Clips or other metallic implanted objects in the skull or the brain, except shunts.\n3. The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).\n4. Patients requiring increasing doses of corticosteroids.\n5. Patient receiving bevacizumab (Avastin) therapy.\n6. Patients with ≥25% increase in volume of contrast enhancement at time of assessment for study enrollment, compared with their first postoperative MRI. This cut-off is used to differentiate between pseudoprogression (which can occur following both radiation and TMZ therapy) and true tumor progression. This will be further ascertained through a discussion between the study neurosurgeons and radiologists.\n7. Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, and focal irradiation with brachytherapy, stereotactic radiosurgery, and laser interstitial thermotherapy. These regimens have been shown to cause contrast enhancement in the resection cavity boundary, which can be difficult to differentiate from true tumor recurrence.\n8. Cardiac disease or unstable hemodynamics including:\n\n   i. Documented myocardial infarction within six months of enrollment. ii. Unstable angina on medication. iii. Congestive heart failure. iv. Left ventricular ejection fraction \\\u003C50%. v. History of a hemodynamically unstable cardiac arrhythmia. vi. Cardiac pacemaker.\n9. Severe hypertension (diastolic blood pressure (DBP) \\> 100 on medication).\n10. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment).\n11. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage.\n12. Abnormal level of platelets (\\\u003C 100,000) or INR \\> 1.3.\n13. Documented cerebral infarction within the past 12 months.\n14. TIA in the last 1 month.\n15. Cerebral or systemic vasculopathy.\n16. Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.\n17. Known sensitivity to gadolinium-DTPA.\n18. Known sensitivity to DEFINITY® ultrasound contrast agent or perflutren.\n19. Contraindications to MRI such as non-MRI-compatible implanted devices, unable to tolerate an MRI due to for instance pain or claustrophobia, untreated, uncontrolled sleep apnea.\n20. Positive pregnancy test (for pre-menopausal women).\n21. Known life-threatening systemic disease.\n22. Severely impaired renal function with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2 and\u002For on dialysis.\n23. Right to left or bi-directional cardiac shunt.\n24. Previous full course of chemotherapy for GBM (at the discretion of investigator).\n25. Previous radiotherapy.\n26. Allergy to eggs or egg products.\n27. Subjects with evidence of cranial or systemic infection.\n28. Subjects with chronic pulmonary disorders.\n29. Subjects with a history of drug allergies, asthma or hay fever, and multiple allergies, in particular subjects with a history of anaphylaxis.\n30. Subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation, or QT prolongation observed on screening ECG (QTc \\> 450 for men and \\>470 for women).\n31. Subjects with evidence of Hepatitis B virus infection\u002Fcarrier state.\n32. Liver injury as indicated by liver function tests that in the Investigator's opinion precludes participation in the study.","85 Years",{"count":209,"type":20},10,[72],"The goal of this clinical trial is to evaluate the safety and feasibility of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) in adults with glioblastoma (GBM) undergoing the maintenance phase of the standard \"Stupp protocol\".\n\nParticipants will:\n\n* Undergo repeated FUS BBB disruption treatments during the maintenance phase of temozolomide (TMZ) chemotherapy.\n* Receive intravenous ultrasound contrast (DEFINITY®) prior to each FUS session to facilitate targeted BBB disruption.\n* Undergo serial MRI scans and clinical assessments to evaluate safety and the extent of BBB opening.\n* Provide blood samples (and tumor tissue if available) for biomarker analysis related to BBB permeability, tumor presence, and treatment response.\n* Be followed for progression-free survival (PFS) and overall survival (OS) during routine neuro-oncology visits until end of life.",[28,29,213,214,215,30,79,78],"Glioblastoma Multiforme of Brain","Glioblastoma Multiforme Glioma","HGG",[217,218,28,219,220,221,222,223,224,225,226],"Focused Ultrasound","FUS","TMZ","Temozolomide","blood-brain barrier disruption (BBBD)","MR-guided Focused Ultrasound (MRgFUS)","Glioblastoma multiforme","blood-brain barrier opening","Drug delivery","Chemotherapy delivery","2025-09-10",{"date":229,"type":51},"2025-09-17",{"date":231,"type":51},"2025-06-04",{"date":233,"type":20},"2027-11",{"name":235,"class":90},"Sunnybrook Health Sciences Centre",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":99,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":153},"100604070","allogeneic-t-cells-in-glioblastoma-100604070","NCT07144735","Allogeneic γδT Cells in Glioblastoma","Allogeneic Gamma Delta (γδ) T Cells for the Treatment of Glioblastoma","ABOUT","Inclusion Criteria:\n\n1. Male or female, age 18-70 years old (both ends included)\n2. At least one evaluable lesion with previous biopsy or pathohistologic confirmation of glioblastoma (WHO grade IV), with imaging suggestive of continued progression or recurrence after comprehensive treatment\n3. Karnofsky Performance Status (KPS) ≥ 60%\n4. Life expectancy \\> 4 weeks\n5. Patients who completed radiotherapy or systemic therapies (including temozolomide\u002Fbevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)\n6. Must be able to undergo an MRI with contrast\n7. Must have adequate organ and marrow function as defined below:\n\n   * White blood cell count (WBC) ≥ 3 x 10\\^9\u002FL\n   * Absolute neutrophil count (ANC) \\> 1 x 10\\^9\u002FL\n   * Hemoglobin (Hb) ≥ 90 g\u002FL\n   * Platelet (PLT) ≥ 80×10\\^9\u002FL\n   * Albumin transaminase (ALT) \\& albumin transaminase (AST) \\\u003C 1.5 × institutional upper limit of normal (ULN)\n   * Serum creatinine (Cr) \\\u003C 1.5 x institutional ULN\n   * Total bilirubin \\\u003C 1.5 x institutional ULN\n   * PT \\& PTT ≤ 1.25 x institutional ULN\n8. No obvious hereditary diseases\n9. Normal cardiac function with left ventricular ejection fraction \\>55%\n10. No bleeding and coagulation disorders\n11. Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to ABOUT γδT cell infusion and\u002For there aren't any indications of meningitis\n12. Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately\n13. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Active hepatitis B or C virus, HIV infection, or other untreated active infection\n2. Pregnant and lactating women\n3. Participants with organ failure\n4. Participants with a chronic disease requiring immunologic or hormonal therapy\n5. Participants with an allergy to immunotherapy and related cells\n6. Participants with uncontrolled intercurrent illness\n7. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n8. Participants with a history of organ transplantation or who are awaiting organ transplantation",{"count":245,"type":20},18,[103],"This first-in-human clinical study aims to evaluate the safety and feasibility of locally delivered, allogeneic γδ T cells (genetically edited with ARIH1 and BCL11b knockout, designated ABOUT γδT cells) in patients with glioblastoma multiforme (GBM). The engineered effector cells are delivered via localized administration to selectively target and eliminate residual GBM cells. ABOUT: ARIH1 and BCL11b knockOUT γδ T cells.",[26,29],[35,250,110,251,252],"Glioblastoma Multiforme","Gamma Delta T Cell","γδT","2025-08-20",{"date":255,"type":51},"2025-08-27",{"date":257,"type":51},"2025-04-01",{"date":259,"type":20},"2030-12",{"name":121,"class":90},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":271,"phases":4,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":282,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":91},"100597007","the-effect-of-glioblastoma-psma-expression-following-tumour-vegf-blockade-from-bevacizumab-100597007","NCT07052877","The Effect of Glioblastoma PSMA Expression Following Tumour VEGF Blockade From Bevacizumab","Investigating Glioblastoma PSMA Expression by Utilizing Anti-VEGF and Its Effect on PSMA PET Scan Avidity","GUAVA","Inclusion Criteria:\n\n* \\> 18 year of age\n* ECOG 0-2\n* Able to provide informed consent for the study\n* Minimum of 1 month from completion of radiotherapy with clinical or radiography evidence suggesting residual tumour\n* Confirmed glioblastoma IDH1\u002F2 wildtype (WHO2021)\n* For bevacizumab treatment as per treating physician\n* Able to comply with trial requirements\n\nExclusion Criteria:\n\n* No major organ impairment that would likely lead to unacceptable toxicities- eg significant cardiac, hepatic, renal or haematologic dysfunction (based on clinician assessment)\n* Any contraindication to bevacizumab, MRI gadolinium contrast or 68Ga-PSMA-617 radioisotope\n* Any implant, foreign body, 3T MRI incompatible device or other contraindication to MRI imaging\n* Does not fulfill PBS requirements for bevacizumab\n* Women lactating, pregnant or of child baring potential who are not willing to avoid pregnancy during the study",{"count":270,"type":20},20,"OBSERVATIONAL","This trial is a single arm study for patients receiving bevacizumab for IDH-wildtype glioblastoma. Patients receiving bevacizumab (an anti-VEGF therapy) will receive PSMA scans to investigate the role of PSMA expression in glioblastoma and its relationship to VEGF expression.",[35,29],[275,276,277,278,279,280,281],"glioblastoma","anti-VEGF","PSMA","bevacizumab","VEGF","glioma","astrocytoma","NOT_YET_RECRUITING","2025-07-08",{"date":285,"type":51},"2025-07-11",{"date":287,"type":20},"2025-07",{"date":289,"type":20},"2027-07",{"name":291,"class":90},"Royal North Shore Hospital",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":162,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},"100564673","phase-1-5g-emerald-amivantamab-in-malignant-brain-tumours-100564673","NCT06632236","5G-EMERALD: Amivantamab in Malignant Brain Tumours","5G-EMERALD: A Phase 1 Trial of Amivantamab in High Grade Malignant Brain Tumours Within the 5G Platform","5G-EMERALD","Inclusion Criteria for Phase 1b:\n\n1. Patients with histologically confirmed advanced WHO Stage IV glioblastoma (per fourth edition 2016). Per the new 2021 fifth edition of WHO Classification of Tumours of the Central Nervous System, this will include:\n\n   * Glioblastoma, IDH-wildtype Grade 4\n   * Astrocytoma, IDH-mutant, Grade 4 (lower Grade 2\u002F3 are not included)\n   * Diffuse hemispheric glioma, H3 G34 mutant Grade 4\n2. Patients for Phase 1 will need to have consented to the Minderoo Precision Brain Tumour Programme and have available whole genome, and transcriptome data available.\n3. Patients for the relapsed cohorts will be eligible at first relapse following completion of optimal surgery, and Stupp based adjuvant chemo-radiotherapy (or equivalent). They will need to have measurable disease per Response Assessment in Neuro-Oncology (RANO) or evaluable disease.\n4. Patients for the front line minimal residual disease (MRD) cohort will be eligible following completion of optimal surgery and Stupp based adjuvant chemoradiotherapy as long as they meet all other inclusion\u002Fexclusion criteria.\n5. 16 years or over.\n6. Life expectancy of at least 12 weeks.\n7. World Health Organisation (WHO) performance status of 0-1.\n8. Neurologically stable (e.g., without a progression of neurological symptoms or requiring escalating doses of systemic steroid therapy within the last week).\n9. Written (signed or dated) informed consent and be capable of co-operating with treatment and follow up.\n10. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP:\n\n    Haemoglobin (Hb): ≥ 10.0 g\u002FdL Absolute neutrophil count: ≥ 1.5 x 10\\^9\u002FL Platelet count: ≥ 75 x 10\\^9\u002FL Coagulation: INR \\\u003C1.5 and APTT \\\u003C1.5x if not anticoagulated INR stable \\> 7 days within intended therapeutic range if anticoagulated Bilirubin: ≤ 1.5 x ULN; subjects with Gilbert's syndrome can enrol if conjugated bilirubin is within normal limits.\n\n    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): \\\u003C 3 x ULN Albumin: ≥ 28 g\u002FL Creatinine: \\\u003C1.5 x ULN and creatinine clearance \\> 45 ml\u002Fmin as measured or calculated based on Cockcroft-Gault formula Sodium: ≥ 130 mmol\u002FL Potassium, Calcium, Magnesium, phosphate: Within institution normal ranges (replacement is permitted) Urinary protein: \\\u003C 1+ on dipstick\n11. Female patients with reproductive potential must have a negative serum, or urine, pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.\n12. A participant must be either of the following: a. not of childbearing potential, b. of child-bearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of the study treatment is given, or c. of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method, to avoid impregnating a partner or becoming pregnant, respectively. A participant must agree to continue contraception throughout the study, and for at least 6 months after the last dose of study treatment.\n\n    Please, refer to section 4.1 of CTFG guidance \"Recommendations related to contraception and pregnancy testing in clinical trials\" and to section 9.6 of the Master Protocol for further details.\n\n    Note: If the childbearing potential changes after start of the study (eg, participant of childbearing potential who is not heterosexually active becomes active, premenarchal participant experiences menarche) the participant must begin birth control, as described above.\n13. A participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.\n14. A participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. A participant who is sexually active with a partner of childbearing potential must agree to use a condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository and their partner must also be practicing a highly effective method of contraception (ie, established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device \\[IUD\\] or intrauterine hormone-releasing system \\[IUS\\]). If the participant is vasectomized, they must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but their partner is not required to use contraception.\n15. A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.\n16. A participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\nExclusion Criteria for Phase 1b:\n\n1. Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:\n\n   * Cytotoxic chemotherapy during the prior 2 weeks or 6 weeks for nitrosoureas\n   * Bevacizumab during the prior 6 weeks\n   * Five half-lives of any small molecule investigational or licensed medicinal product.\n2. Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted. Prior EGFR-targeting therapy is not permitted. Prior use of any other immune-modulatory investigational agent must be discussed with sponsor team and CI.\n3. Ongoing Grade 2 or greater toxicities from pre-existing conditions or from previous treatments.\n4. Patients with carcinomatous meningitis, leptomeningeal spread of tumour, spread of tumour to the brain stem or spinal cord.\n5. Has evidence of recent intratumoural or peritumoural haemorrhage on baseline MRI. Patients with radiological findings that are stable on at least 2 consecutive MRI scans at least 3 weeks apart will be eligible.\n6. History of clinically relevant bleeding disorders, including significant gastrointestinal (GI) bleeding within last 6 months.\n7. Participant has active cardiovascular disease including, but not limited to:\n\n   * A medical history of deep venous thrombosis or pulmonary embolism within 1 month prior to first dose of study drug or any of the following within 6 months prior to first dose of study drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary\u002Fperipheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis such as non-obstructive catheter-associated thrombus, incidental or asymptomatic pulmonary embolism, are not exclusionary. Patients on Warfarin will need to be converted onto low-molecular weight-based heparin therapy.\n   * Participant has a significant genetic predisposition to venous thromboembolic (VTE) events such as Factor V Leiden.\n   * Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network (NCCN) or local guidelines.\n   * Uncontrolled (persistent) hypertension: systolic blood pressure \\> 160 mm Hg; diastolic blood pressure \\> 100 mm Hg.\n   * Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class) within 6 months of first dose of the study drug.\n   * Concurrent and clinically significant abnormalities on ECG at Screening, including a corrected QT interval (QTcF \\> 460ms).\n8. History of malabsorption syndrome or other conditions that may interfere with enteral absorption. Patients with a history of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). Patients with acute or chronic pancreatitis. History of GI perforation or fistulae.\n9. Has urine protein \\> 1g\u002F24 hours. Participants with \\> 1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n10. Has significant lung disease including pneumonitis, interstitial lung disease (including drug-induced or radiation ILD\u002Fpneumonitis), idiopathic pulmonary fibrosis, cystic fibrosis, active tuberculosis, or history of opportunistic infections (including PCP or Cytomegalovirus (CMV) pneumonia).\n11. Participant is serologically positive for hepatitis B surface antigen (HbsAg), Note: participants with a prior history of hepatitis B virus (HBV) demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.\n12. Participant is serologically positive for hepatitis C antibody. Note: participants with a prior history of hepatitis C virus (HCV), who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.\n13. Participant has other clinically active infectious liver disease.\n14. Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:\n\n    * Receiving antiretroviral therapy (ART) that may interfere with study treatment (consult sponsor for review of medication prior to enrolment).\n    * CD4 count \\\u003C 350 at screening\n    * AIDS-defining opportunistic infection within 6 months of start of screening\n    * Not agreeing to start ART and be on ART \\> 4 weeks plus having HIV viral load \\\u003C 400 copies\u002FmL at end of 4-week period (to ensure ART is tolerated and HIV controlled).\n15. Participant has an uncontrolled illness, including but not limited to:\n\n    * Uncontrolled diabetes\n    * Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \\[participants will be required to complete antibiotics 1 week prior to starting study treatment\\] or diagnosed or suspected viral infection.\n    * active bleeding diathesis\n    * Impaired oxygenation requiring continuous oxygen supplementation\n    * Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements\n    * Any ophthalmologic condition that is clinically unstable\n16. Steroid requirement for neurological symptom control of \\> 3mg Dexamethasone per day (patients will allowed to enrol if they have been on a stable dose of steroids of equivalent or less than 3mg Dexamethasone for at least 5 days prior to Day 1 of Cycle 1).\n17. Has received a live vaccine within 30 days of planned start of study therapy. Note: inactive vaccines including COVID vaccines are allowed prior to 1 week of Day 1 of Cycle 1).\n18. Concurrent or prior malignancy other than the disease under study. The following exceptions require consultation with the Chief Investigator:\n\n    1. Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured.\n    2. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is completely cured.\n    3. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n19. Is a participant or plans to participate on another interventional clinical trial while taking part in this Phase 1 study. Participation in an observational trial would be acceptable.\n20. A participant has major surgery excluding placement of vascular access or tumour biopsy, or had significant traumatic injury within 4 weeks before first dose of study drug or minor surgery within 2 weeks, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Note: Participants with planned surgical procedures to be conducted under local anaesthesia may participate.\n21. A participant has palliative radiotherapy within 1 week of the firs dose of study drug,\n22. Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.",{"count":301,"type":20},12,[72],"The purpose of this clinical trial is to evaluate the safety and tolerability of amivantamab and to determine the preliminary antitumour activity of amivantamab administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study a biomarker defined arm will be opened, initially in the relapsed GMB setting, enrolling 12 patients. These patients will be treated with amivantamab monotherapy. Amivantamab will be administered intravenously (IV) weekly for the first 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity. The first dose will be given as a split infusion, 350 mg IV over 4 hours on cycle 1 day 1 and 1400 mg IV over 6 hours on cycle 1 day 2. Subsequent infusions are given at a dose of 1750 mg IV over 2-5 hours in cycle 1 and between 2-3 hours from cycle 2 onwards if the first dose was well-tolerated with no significant toxicity.\n\nProgression to Phase 2 is dependent on emergent data and funding.",[168,191,192,29],"2025-04-23",{"date":307,"type":51},"2025-04-25",{"date":309,"type":51},"2024-10-09",{"date":311,"type":20},"2027-03-05",{"name":177,"class":90},2,{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":271,"phases":4,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":282,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":91},"100588284","photodynamic-therapy-for-glioblastoma-multiforme-based-on-metaverse-and-yellow-fluorescence-100588284","NCT06939400","Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence","Study on Precision Photodynamic Therapy for Glioblastoma Multiforme Based on Metaverse and Yellow Fluorescence","Inclusion Criteria:\n\nPathologically confirmed primary focal GBM; Recurrent GBM(single or satellite lesions); Multiple (multiple germinal centers)GBM.\n\nExclusion Criteria:\n\n* Photosensitizer allergy.\n\n  * Severe coagulation disorder.\n\n    * Patients with severe cardiovascular and cerebrovascular diseases, especially patients in the acute stage.\n\n      * Multiple organ failure, end-stage patients. ⑤ Pregnant women: Photofrin is considered a class C pregnancy risk (toxic, non-teratogenic) drug with non-dialysis properties.\n\nNon-gbm diagnosis: Patients with other types of brain tumors or diseases. 7 Do not agree to informed consent: patients who are unwilling to sign informed consent or do not agree to participate in the study.",{"count":322,"type":20},100,"GBM patients receiving PDT treatment (50 cases，surgery combined with photodynamic therapy) and traditional treatment (50 cases，traditional surgery) in our hospital and partner hospitals were collected. The prognosis was analyzed by comparing with the control group from multiple perspectives such as image evaluation, imaging effect, Karnofsky score, median survival time and survival rate.",[29],[250,326,327,328],"photodynamic therapy","metaverse","yellow fluorescence","2025-04-14",{"date":331,"type":51},"2025-04-22",{"date":333,"type":20},"2025-06-01",{"date":335,"type":20},"2027-12-31",{"name":337,"class":90},"Zhejiang Provincial People's Hospital",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":21,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":282,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"locationsCount":91},"100576136","patients-derived-organoids-for-drug-screening-in-glioblastoma-100576136","NCT06781372","Patient's Derived Organoids for Drug Screening in Glioblastoma","Development and Characterization of Patient's Derived Organoids as a Platform for the Screening of Novel Therapeutic Treatments for Glioblastoma Multiforme","GlioPDO","Inclusion Criteria:\n\n* adult patients undergoing resective neurosurgery for glioblastoma, IDH-wildtype\n\nExclusion Criteria:\n\n* Needle biopsies\n* Age \\\u003C18 years\n* Inability to give informed consent\n* Brain surgery for tumor disease other than GBM\n* Previous neoadjuvant chemotherapy or radiotherapy",{"count":322,"type":20},[103],"The study will enroll patients suffering from glioblastoma, a malignant brain tumor. Intervention is intended as a laboratory intervention and not as a clinical intervention. In fact, tumor removed from patients' brains will be sent to a dedicated laboratory to obtain an \"avatar\" of the tumor, named patient-derived organoid (PDO). A number of experimental antitumor approaches will be studied on PDOs. Results of these experiments will be correlated to the prognosis of patients.",[35,29,350],"Glioblastoma Multiforme, Adult",[275,352,353,354,355],"patient derived organoid","transposable elements","splicing","immunotherapy","2025-03-11",{"date":358,"type":51},"2025-03-13",{"date":257,"type":20},{"date":361,"type":20},"2028-01-31",{"name":363,"class":90},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":21,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":91},"100561824","phase-2-jk-1201i-combined-with-adjuvant-temozolomide-in-patients-with-newly-diagnosed-glioblastoma-multiforme-gbm-100561824","NCT06595186","JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)","A Multicenter, Single Arm, Open-label, Dose-escalation Phase 2 Study of JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) After Surgery and Concomitant Radio-chemotherapy","Inclusion\n\nParticipants must meet all the following criteria to be eligible for randomization into the study:\n\n1. Male or female aged ≥18 years and ≤75 years.\n2. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%.\n3. Patients must finish concurrent chemo-radiotherapy (CCRT) no sooner than 4 weeks and no later than 6 weeks.\n4. Stable dose or reduced dose of corticosteroid for more than 2 weeks.\n5. Karnofsky score ≥ 70.\n6. Life expectancy \\> 12 weeks.\n7. Adequate biological function.\n8. Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.\n9. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.\n10. MGMT unmethylation (only for Dose Expansion Cohort).\n\nExclusion\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Patients who received anti-tumor therapy except for concurrent chemo-radiotherapy (CCRT).\n2. Patient diagnosed with brain stem and spinal cord tumor as the primary tumor.\n3. Hypersensitivity to any ingredient of JK-1201I.\n4. Severe, uncontrolled or active cardiovascular diseases within the past 6 months.\n5. Inability to take medication by oral or presence of clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.\n6. Uncontrolled seizures.\n7. Patient receiving prohibited medications and that cannot be discontinued at least 2 weeks prior to the start of treatment.\n8. Severe or uncontrolled high blood pressure.\n9. Unresolved toxicity from prior anti-tumor therapy.\n10. Women who are pregnant or Breast-feeding. 11 Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or active hepatitis C virus infection.\n\n12\\. Have participated in another clinical trial within 4 weeks prior to informed consent form.\n\n13\\. History of mental disorders. 14. Other conditions that the investigator considers unsuitable to participate in this clinical trial.","75 Years",{"count":373,"type":20},25,[23],"This study was designed to evaluate the safety, tolerability, efficacy and pharmacokinetics of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.",[29],[378],"glioblastoma multiforme","2024-09-11",{"date":381,"type":51},"2024-09-19",{"date":383,"type":51},"2022-10-31",{"date":385,"type":20},"2026-12-16",{"name":387,"class":58},"JenKem Technology Co., Ltd."]