[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neonc Technologies, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":162},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,74,96,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":48,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100519732","phase-1-safety-and-efficacy-of-neo212-in-patients-with-astrocytoma-idh-mutant-glioblastoma-idh-wildtype-or-brain-metastasis-100519732",false,"NCT06047379","Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis","An Open-label Phase 1\u002F2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.","Inclusion Criteria:\n\n* Patient must be ≥ 18yrs of age.\n* Patient must have the ability to understand, and the willingness to sign, a written informed consent form.\n* Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n* Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.\n* If progression of disease occurs within 90 days or conformal radiation, the progression\u002Frecurrence must be outside of the radiation field or proven by biopsy\u002Fresection.\n* Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.\n* Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patient must have an expected survival or at least three months.\n* Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.\n* Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.\n* Patients must be able to comply with all study assessments.\n* If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.\n* Patient must have adequate organ and marrow function as follows:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n  * Platelets ≥ 100,000\u002Fmicroliter\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) \u002F ALT (SPGT) ≤ 2.5 x institutional upper limit of normal\n  * Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24- hour urine collection).\n* Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nA female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).\n* A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.\n* A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n\nPhase 1: (dose escalation)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:\n\n  * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;\n  * 2 weeks from administration of immunotherapies;\n  * 28 days from administration of cytotoxic agents; and\n  * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).\n\nNOTE: No washout is necessary for alternating electrical fields.\n\nPhase 2a: (safety run-in)\n\n* Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria.\n* Patient must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n\nPhase 2b: (efficacy)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria\n* Patient with select solid tumors must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n* Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria: (all Phases)\n\n* Patient in Phase 1 concurrently receiving any other antitumor therapy.\n* Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.\n* Patients with metastases to the spinal cord parenchyma.\n* Patients with metastases to the meninges.\n* Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.\n* Patient with history of known leptomeningeal involvement.\n* Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and\u002For the use of concomitant medications that prolong QT\u002FQTc interval.\n* Patient had surgery within 7 days prior to the date of informed consent.\n* Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.\n* Patient had prior treatment with perillyl alcohol.\n* Patient has a history of allergic reactions attributed to perillyl alcohol.\n* Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his\u002Fher primary CNS tumor(s).","ALL","18 Years",{"count":19,"type":20},134,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This multi-site, Phase 1\u002F2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.\n\nThe study will have three phases, Phase 1, Phase 2a and Phase 2b.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47],"Diffuse Astrocytoma, IDH-Mutant","Glioblastoma, IDH-wildtype","Brain Metastases, Adult","Cervical Cancer","Colorectal Cancer","Esophageal Cancer","Esophageal Squamous Cell Carcinoma","Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","Melanoma","Merkel Cell Carcinoma","Microsatellite Instability-High Solid Malignant Tumor","Mismatch Repair Deficient Solid Malignant Tumor","Microsatellite Instability-High Colorectal Cancer","Mismatch Repair Deficient Colorectal Cancer","Non-small Cell Lung Cancer","Renal Cell Carcinoma","Small Cell Lung Cancer","Squamous Cell Carcinoma","Urothelial Carcinoma",[49,50,51,52,53,54,55,56,57,58,59,60],"Astrocytoma","IDH-mutant","Glioblastoma","IDH-wildtype","Brain Metastases","CNS Tumor","GBM","NeOnc","Anova","NEO212","NEO100","TMZ","RECRUITING","2026-02-27",{"date":64,"type":65},"2026-03-02","ACTUAL",{"date":67,"type":65},"2023-11-01",{"date":69,"type":20},"2027-08-31",{"name":71,"class":72},"Neonc Technologies, Inc.","INDUSTRY",6,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100441030","phase-2-neo100-and-high-grade-meningioma-100441030","NCT05023018","NEO100 and High-Grade Meningioma","An Open-Label, Phase 2 Study of NEO100 in Participants With Residual, Progressive or Recurrent High-Grade Meningioma","Inclusion Criteria\n\nPatient must:\n\n1. Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed.\n\n   1. Residual disease is defined as residual measurable disease (without a requirement for progression). Residual measurable disease is defined by bidimensionally measurable lesions with clearly defined margins by MRI scan(s) with a minimum diameter of 10mm in both dimensions.\n   2. Progressive disease is defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area). The change must occur between scans separated by no more than 24 months.\n   3. Recurrent disease is defined as new evidence of measurable disease following complete resection (10mm in both dimensions).\n2. Be on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n3. Participants must have failed maximal safe resection and radiation therapy.\n4. There is no limit on the number of prior surgeries, radiation therapy, radiosurgery treatments or systemically administered therapeutic agents, however, these treatment(s) must comply with the following:\n\n   1. There is no limit on the number of prior therapies.\n   2. Prior medical therapy is allowed but is not required.\n   3. No chemotherapy, other investigational agents within 14 days of study treatment.\n   4. For prior systemic agents, participants must be at least 4 weeks (or 5 half-lives, whichever is shorter) from other prior cytotoxic chemotherapy (6 weeks from nitrosoureas\u002Falkylating agents) or biologic therapies.\n   5. No other concurrent receipt of investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study.\n   6. Patients may have been treated with standard external beam radiation or radiosurgery in any combination; however an interval of ≥12 weeks (84 days) must have elapsed from the completion of the radiation therapy to the initiation of study therapy unless there is histopathologic confirmation of recurrent tumor or there is new enhancing tumor outside the radiation field (beyond the high dose region or the 80% isodose line). In addition, there must be subsequent evidence of tumor progression after completion of radiation therapy;\n   7. An interval of ≥ 28 days and full recovery (no ongoing safety issues) from surgical resection is required;\n   8. Meningiomas that have resulted from prior radiation therapy are allowed.\n   9. There must be an interval of ≥ 7 days from stereotactic biopsy; and\n5. Participants must have recovered to grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include, but are not limited to alopecia, laboratory values listed per inclusion criteria and lymphopenia)\n6. Patient must be ≥ 12 years of age.\n7. Patient must have an ECOG performance status of 0-2 or KPS ≥ 60.\n8. Patient must have an expected survival of at least three months.\n9. Patient must be willing to provide blood sample for pharmacokinetic study (to assess proper administration of NEO100).\n10. Patient must have adequate organ and marrow function as defined below:\n11. White blood cell (WBC) ≥2000\u002Fmicroliter\n12. Absolute neutrophil count (ANC) ≥ 1,500\u002Fmicroliter\n13. Platelets ≥ 100,000\u002Fmicroliter\n14. Hemoglobin ≥9 gm\u002Fdl\n15. AST (SGOT)\u002FALT (SPGT) ≤ 2.5 × laboratory upper limit of normal (ULN)\n16. Serum creatinine ≤ 1.5 x laboratory upper limit of normal (ULN) or\n17. Creatinine clearance (meas or calc) ≥60mL\u002Fmin for participants with creatinine levels \\>1.5x laboratory upper limit of normal (ULN)\n18. Total serum bilirubin ≤ 1.5 x laboratory upper limit of normal (ULN) except participants with Gilbert's Syndrome who can have a total serum bilirubin of \\\u003C5 x laboratory upper limit of normal (ULN)\n19. MRI (or CT if MRI contraindicated) within 14 days prior to start of study drug. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening scan and the start of treatment, a new baseline scan is required.\n20. Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first administration of study drug, for the duration of study participation, and for 90 days following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n21. A female of child-bearing potential is any woman (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n    1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n    2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n22. A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to initiating study drug.\n23. A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n24. Women must not be breastfeeding.\n25. Patient must have the ability to understand, and the willingness comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study as confirmed by signing a written informed consent document.\n\nExclusion Criteria\n\n1. Patients who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days (or 5 half-lives, whichever is shorter) of study treatment.\n2. Patient has completed chemo-radiation within the last 84 days prior to the first administration of study drug, unless new contrast enhancement is outside of radiation field, or there is tissue proven recurrence or progression.\n3. Patient has had surgery within seven days prior to the date of informed consent.\n4. Patient has had cytotoxic chemotherapy within 4 weeks (or 5 half-lives, whichever is shorter), nitrosoureas\u002Falkylating agents within 6 weeks or biologic therapies.\n5. Prior treatment with interstitial brachytherapy within 6 months of start of study therapy.\n6. Current or planned participation in a clinical trial of an investigational agent or using an investigational medical device.\n7. The patient's disease is primarily localized to the brainstem or spinal cord;\n8. Patient has not recovered from adverse events due to chemotherapy, immunotherapy, or radiation therapy.\n9. Patient has had prior treatment with perillyl alcohol.\n10. Patient has a history of allergic reactions attributed to perillyl alcohol.\n11. Patient has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n12. Patient must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n13. Patient has a history of new diagnosis or treatment of cancer other than high-grade meningioma within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n14. Leptomeningeal involvement of the patient's tumor.","12 Years",{"count":83,"type":20},30,[24],"This multi-site, Phase 2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma. There will be up to 30 patients enrolled in this study to have 29 evaluable patients. NEO100 will be self-administered four times daily on a 28-day treatment cycle until disease progression, death or patient withdraw from study for any reason, whichever occurs first.",[87],"Residual, Progressive or Recurrent Grade II or III Meningioma",[87],{"date":64,"type":65},{"date":91,"type":65},"2022-07-01",{"date":93,"type":20},"2027-06-30",{"name":71,"class":72},3,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100263144","phase-1-safety-and-efficacy-study-in-recurrent-or-progressive-grade-iii-or-iv-idh1-mutated-glioma-100263144","NCT02704858","Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma","An Open-Label, Phase 1\u002F2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or Grade IV Gliomas With IDH1 Mutation","Inclusion Criteria\n\nTo be eligible to participate in the study, a patient must meet all of the following inclusion criteria:\n\n* Patient must have radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma, including infratentorial (brainstem, cerebellar) glioma (confirmed by biopsy) and subcortical glioma.\n* Patient must have radiographically-confirmed progression of, recurrent, primary or secondary Grade III astrocytoma.\n* All patients must be on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n* Patient must have failed previous radiation treatment or combined treatment with temozolomide and radiation.\n* If progression of disease occurs within 90 days of conformal radiation, the progression\u002Frecurrence must be outside of the radiation field or proven by biopsy\u002Fresection.\n* Patient must be ≥ 18 years of age.\n* Patient must have an ECOG performance status of 0-2 or KPS ≥ 60 (the latter for Phase 1 only).\n* Patient must have an expected survival of at least three months.\n* Patient must have a baseline MRI with gadolinium within 14 days of first administration of study drug.\n* Patient must be willing to provide blood samples for pharmacokinetic study.\n* If patient suffers from seizures, (s)he must be controlled on a stable dose of anti- epileptics for 14 days prior to the date of informed consent.\n* Patient must have adequate organ and marrow function as defined below:\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin within normal institutional limits\n* AST (SGOT)\u002FALT (SPGT)≤ 2.5 × institutional upper limit of normal\n* Creatinine within normal institutional limits\n* Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first administration of study drug, for the duration of study participation, and for 90 days following completion of therapy. Should a female patient become pregnant, or suspect she is pregnant, while participating in this study, she should inform her treating physician immediately.\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to initiating study drug.\n* A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n* Patient must have the ability to understand, and the willingness to sign, a written informed consent.\n\nPhase 2a\n\nIn addition to meeting Inclusion Criteria for the Phase I portion of the study, patients eligible for participation in the Phase 2a portion of the study must additionally meet the following criteria:\n\n• Patients must have a confirmed IDH1 mutation by reverse transcription polymerase chain reaction (rtPCR) or immunohistochemistry (unless continuing into the Phase 2a portion of the study from the Phase I portion of the study).\n\nExclusion Criteria\n\n* If the patient meets any of the following criteria, the patient must not be enrolled:\n* The size of the tumor is \\> 30mm (length x width), as assessed at the baseline (pre- study) MRI evaluation.\n* The tumor is multi-focal, as assessed at the baseline (pre-study) MRI evaluation.\n* Patient has completed chemo-radiation within the last 90 days prior to first administration of study drug, unless new contrast enhancement is outside of radiation field, or there is tissue proven recurrence or progression.\n* Patient has had surgery within seven days prior to the date of informed consent.\n* Patient has had any form of anti-cancer therapy or treatment within 28 days prior to first administration of study drug.\n* Patient has not recovered from adverse events due to chemotherapy, immunotherapy, or radiation therapy administered more than 28 days prior to first administration of study drug.\n* Patient has had prior treatment with bevacizumab, a chemotherapy wafer implant (Gliadel®), or any other FDA-approved anti-cancer therapy or treatment except temozolomide.\n* Patient has had more than one recurrence or progression of his\u002Fher tumors.\n* Patient has received any other investigational agents within 28 days prior to the first administration of study drug.\n* Patient has had prior treatment with perillyl alcohol, administered either intravenously or intranasally.\n* Patient has a history of allergic reactions attributed to perillyl alcohol.\n* Patient has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patient must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n* Patient has a history of new diagnosis or treatment of cancer other than malignant glioma within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* Leptomeningeal involvement of the patient's tumor.",{"count":104,"type":20},49,[23,24],"This multi-site, Phase 1\u002F2a clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with radiographically-confirmed progression of Grade IV glioma or recurrent primary or secondary Grade IV glioma. The study will have two phases, Phase 1 and Phase 2a. Phase 1 is a standard cohort dose escalation 3+3 design used to determine the maximum tolerated dose for Phase 2a. There will be up to 24 patients enrolled in Phase 1. There will be 25 patients enrolled in Phase 2a. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day treatment cycles until disease progression, death or patient withdraw from study for any reason, whichever occurs first.\n\nVersion 10 of the protocol changed the inclusion criteria for Phase 2a to limit inclusion to those patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations. Prior to the protocol amendment, 4 patients were enrolled who were IDH1 wild-type. Therefore, an additional 28 patients will be recruited for a total of 32 patients enrolled into Phase 2a of this study to have 35 evaluable cases.\n\nVersion 12 of the protocol expanded the inclusion criteria for Phase 2a to include those patients with progressive or recurrent Grade III Astrocytoma expressing IDH1 mutations.\n\nReview of the literature specific to these patients found the same expected time to progression and death. As a result, the number of patients to enroll remains 32 to have 35 evaluable cases.",[108],"Glioblastoma Multiforme",[110,111],"recurrent glioblastoma","recurrent GBM",{"date":64,"type":65},{"date":114,"type":65},"2017-08-01",{"date":116,"type":20},"2026-06",{"name":71,"class":72},12,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":126,"maxAge":17,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":139,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100543554","phase-1-a-study-of-the-safety-dosing-and-delivery-of-neo100-in-patients-with-pediatric-brain-tumors-100543554","NCT06357377","A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors","An Open Label, Phase 1b Safety, Dose-finding, Brain Tumor Delivery, and Pharmacokinetics Study of Intranasal NEO100 in Patients With Pediatric-type Select Brain Tumors","Inclusion Criteria:\n\n* Patient must have radiographically confirmed, newly diagnosed or recurrent pediatric-type high grade glioma: Diffuse Midline Glioma, H3 K27-altered; Diffuse hemispheric glioma, H3 G34-mutant, Diffuse pediatric-type HGG, grade III and IV H3-wildtype and IDH-wildtype with imaging and\u002For pathology consistent with a DMG, (including spinal cord tumors); or Recurrent malignant tumors involving the brainstem or posterior fossa (choroid plexus carcinoma, CNS embryonal tumors, and pineoblastoma).\n* Karnofsky ≥ 50 for patients \\> 16 years of age or Lansky ≥ 50 for patients ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* If clinically indicated, participants must be willing to provide adequate tissue for PK analysis, either from a surgical biopsy or needle biopsy.\n* Aged ≥5 to ≤18 years.\n* Patients recurrent or progressive disease must have recovered from all acute side effects of prior therapy.\n* From the projected start of scheduled study treatment, the following time periods must have elapsed: At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.\n* Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg\u002Fm2 \u002Fdose continuously during radiation therapy for 42 days) or dexamethasone is allowed.\n* Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 3 days prior to baseline magnetic resonance imaging (MRI) scan.\n* Surgical Resection: Patients may not have had a surgical resection within four weeks of starting NEO100 and any post-surgical complications must have resolved prior to initiation of NEO100.\n* Radiation Therapy: Patients may not receive radiation therapy within four weeks of starting NEO100. Patients may not be enrolled if they require radiation therapy during Cycle 1 (the DLT Period). Patients may have SOC radiation therapy in Cycle 2 or beyond but will require a second DLT evaluation period to participate.\n* Peripheral absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 (1.0g\u002Fl) AND\n* Platelet count ≥ 100,000\u002Fmm\\^3 (100x10\\^9\u002Fl) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m\\^2.\n* Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age.\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase (ALT)) ≤ 2 x ULN.\n* Serum albumin ≥ 2 g\u002FdL.\n* No or mild renal impairment (i.e., 60 mL\u002Fmin or 1.73m2 with Schwartz equation).\n* No evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry of \\> 92% while breathing room air.\n* Participants with seizure disorder may be enrolled if seizure disorder is well controlled.\n* The effects of the study drugs on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception. Adequate methods include: hormonal or barrier method of birth control; or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Males treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.\n* A legal parent\u002Fguardian and patient must be able to understand, and willing to sign, a written informed consent (parental permission) or assent document, as appropriate.\n\nExclusion Criteria:\n\n* Diagnosis of any pediatric-type glioma not described in inclusion criteria.\n* Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy\u002Fresection should be discussed with the Medical Monitors.\n* Participants who are currently receiving other anti-cancer agents.\n* Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV) or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy. Note: Participants that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-intravenous (IV) steroids are not necessarily excluded from the study but need to be discussed with the Medical Monitor.\n* A marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>450 milliseconds (ms).\n* A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT\u002FQTc interval.\n* Participants with uncontrolled infection or other uncontrolled systemic illness.\n* Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).\n* Active illicit drug use or diagnosis of alcoholism.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in study.\n* Evidence of disseminated disease, including diffuse leptomeningeal disease or evidence of CSF dissemination as determined based upon available clinical details and not a study required MRI study or CSF test.\n* Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug.\n* Concomitant use of potent CYP3A4\u002F5 inhibitors during the treatment phase of the study and within 72 hours prior to starting study drug administration.\n* Concomitant use of potent CYP3A4\u002F5 inducers, which include enzyme inducing antiepileptic drugs (EIAEDs), during the treatment phase of the study and within 2 weeks prior to starting treatment. Concurrent corticosteroids are allowed.","5 Years",{"count":118,"type":20},[23],"This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection\u002Fneedle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid).",[131,132,133,134,135,136,137,138],"Pediatric Tumor of CNS","Pediatric Tumor of Brain","Diffuse Midline Glioma, H3 K27M-Mutant","Pediatric Tumor of Brain Stem","Pineocytoma","Choroid Plexus Carcinoma, Childhood","Spinal Cord Tumor","High Grade Glioma",[140,141,142,143,144,145,146,52,147,148,149,150,151,152,59],"High grade glioma","Diffuse Midline Glioma","H3 K27-altered","Diffuse hemispheric glioma","H3 G34-mutant","Diffuse pediatric-type HGG","H3-wildtype","spinal cord tumors","Brainstem","Posterior fossa","Choroid plexus carcinoma","CNS embryonal tumors","Pineoblastoma","NOT_YET_RECRUITING","2026-01-13",{"date":156,"type":65},"2026-01-14",{"date":158,"type":20},"2026-01",{"date":160,"type":20},"2026-10",{"name":71,"class":72},""]