[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-multiform-grade-iv-astrocytoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-multiform-grade-iv-astrocytoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100564521","phase-1-5g-ruby-avutometinib-and-defactinib-in-malignant-brain-tumours-100564521",false,"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.","ALL","16 Years",{"count":20,"type":21},182,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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.",[28,29,30,31],"Glioblastoma Multiforme (GBM)","Glioblastoma Multiform (Grade IV Astrocytoma)","Diffuse Hemispheric Glioma, H3 G34-Mutant","Malignant Primary Gliomas","RECRUITING","2026-01-19",{"date":35,"type":36},"2026-01-21","ACTUAL",{"date":38,"type":36},"2024-11-15",{"date":40,"type":21},"2030-09-30",{"name":42,"class":43},"Institute of Cancer Research, United Kingdom","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100582919","a-supportive-group-intervention-for-caregivers-to-patients-diagnosed-with-a-glioblastoma-100582919","NCT06869577","A Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma","Project SUGRI - a Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma","SUGRI","Inclusion Criteria:\n\n* Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered Stupps treatment regime.\n\nExclusion Criteria:\n\n* Participants who do not understand, read, and speak Danish.","18 Years",{"count":54,"type":21},24,[56],"NA","Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma.",[59,29],"Caregiver",[61,62,63,64,65],"caregiver","intervention","group","supportive care","glioblastoma","NOT_YET_RECRUITING","2025-04-28",{"date":69,"type":36},"2025-04-29",{"date":71,"type":21},"2025-05-01",{"date":73,"type":21},"2025-12-31",{"name":75,"class":43},"Rigshospitalet, Denmark",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"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":86,"type":21},12,[24],"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.",[31,29,30,28],"2025-04-23",{"date":92,"type":36},"2025-04-25",{"date":94,"type":36},"2024-10-09",{"date":96,"type":21},"2027-03-05",{"name":42,"class":43},2]