[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519732":3},{"organization":4,"armGroups":7,"interventions":50,"overallOfficials":110,"centralContacts":119,"locations":129,"responsibleParty":226,"collaborators":124,"id":228,"slug":124,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":124,"eligibilityCriteria":233,"healthyVolunteers":229,"sex":234,"minAge":235,"maxAge":124,"enrollmentInfo":236,"targetDuration":124,"studyType":239,"phases":240,"briefSummary":243,"conditions":244,"keywords":266,"overallStatus":132,"whyStopped":124,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},{"fullName":5,"class":6},"Neonc Technologies, Inc.","INDUSTRY",[8,15,20,25,30,36,42,46],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 2a Safety Run-In - NEO212 and Ipilimumab","EXPERIMENTAL","\\- Unresectable or metastatic melanoma with uncontrolled metastases to the brain.\n\nNEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules.\n\nIpilimumab - 3 mg\u002Fkg administered IV over 90 minutes every 3 weeks for a maximum of 3 doses per package insert.",[13,14],"Drug: NEO212 Oral Capsule","Drug: Ipilimumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase 2a Safety Run-In - NEO212 and Pembrolizumab","The following primary cancers with uncontrolled metrastases to the brain:\n\n* Unresectable or metastatic melanoma.\n* NSCLC expressing PD-L1, with no EGFR or ALK genomic tumor aberrations.\n* Metastatic NSCLC whose tumors express PD-L1.\n* EGFR or ALK genomic tumor aberrations must have disease progression.\n* SCLC.\n* Unresectable, recurrent HNSCC whose tumors express PD-L1.\n* HNSCC on or after platinum-containing chemotherapy.\n* Urothelial carcinoma whose tumors express PD-L1.\n* Urothelial carcinoma.\n* Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).\n* Microsatellite Instability-high or Mismatch Repair Deficient Colorectal Cancer (CRC).\n* Gastric or gastroesophageal junction adenocarcinoma.\n* Esophageal or gastroesophageal juncUon (GEJ).\n* Cervical cancer.\n* Merkel cell carcinoma.\n\nNEO212 - Same as Arm 1.\n\nPembrolizumab - 200 mg administered every 3 weeks per package insert.",[13,19],"Drug: Pembrolizumab",{"label":21,"type":10,"description":22,"interventionNames":23},"Phase 2a Safety Run-In - NEO212 and Nivolumab","The following primary cancers with uncontrolled metrastases to the brain:\n\n* Unresectable or metastatic melanoma.\n* Metastatic non-small cell lung cancer.\n* Advanced renal cell carcinoma.\n* Squamous cell carcinoma of the head and neck.\n* Urothelial carcinoma.\n* Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.\n* Unresectable esophageal squamous cell carcinoma (ESCC).\n\nNEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules.\n\nNivolumab - 240 mg administered every 2 weeks per package insert",[13,24],"Drug: Nivolumab",{"label":26,"type":10,"description":27,"interventionNames":28},"Phase 2a Safety Run-In - NEO212 and Stivarga (Regorafenib)","\\- Colorectal cancer (CRC) with uncontrolled metastases to the brain who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anU-EGFR therapy.\n\nNEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules.\n\nStivarga - 160 mg orally, once daily for the first 21 days of each 28-day cycle per package insert",[13,29],"Drug: Regorafenib",{"label":31,"type":10,"description":32,"interventionNames":33},"Phase 2a Safety Run-In - NEO212 and CarbolaUn (ParaplaUn) + Paclitaxel (Taxol)","\\- Colorectal cancer (CRC) with uncontrolled metastases to the brain.\n\nNEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules.\n\nCarboplatin - 300 mg\u002Fm2 IV on day 1 every 4 weeks for 6 cycles per package insert.\n\nPaclitaxel - 135mg\u002Fm2 IV administered over 24 hours, every 3 weeks per package insert.",[13,34,35],"Drug: Carboplatin","Drug: Paclitaxel",{"label":37,"type":10,"description":38,"interventionNames":39},"Phase 2a Safety Run-In - NEO212 and FOLFIRI (Zaltrap) + Bevacizumab (Avastin)","\\- Metastatic colorectal cancer (mCRC) with uncontrolled metastases to the brain, that is resistant to or has progressed following an oxaliplatin-containing regimen\n\nNEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules.\n\nFOLFIRI - 4 mg\u002Fkg aIV over 1 hour every 2 weeks.\n\nBevacizumab - 10 mg\u002Fkg IV every 2 weeks.",[13,40,41],"Drug: FOLFIRI Protocol","Drug: Bevacizumab",{"label":43,"type":10,"description":44,"interventionNames":45},"Phase 2b efficacy - NEO212 for Astrocytoma IDH-mutant and Glioblastoma IDH-wildtype","Patients receiving NEO212 alone for treatment of Astrocytoma IDH-mutant and Glioblastoma IDH-wildtype.\n\nNEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules.",[13],{"label":47,"type":10,"description":48,"interventionNames":49},"Phase 2b efficacy - NEO212 & SOC for Uncontrolled Metastases to the Brain","Patients receiving NEO212 in combination with select standard of care treatments for treatment of uncontrolled metastases to the brain.\n\nNEO212 - Starting one dose level under RP2D administered orally on days 1 - 5 of a 28-day treatment cycle, escalated to RP2D per Protocol dose escalation rules.\n\nSOC treatments established to be safe in Phase 2a of the study will be used in this arm of Phase 2b.",[13,14,19,24,29,34,35,40,41],[51,58,64,70,76,82,88,94,100],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DRUG","NEO212 Oral Capsule","NEO212 is a novel chemical entity that was generated by covalent conjugation of temozolomide (TMZ) with perillyl alcohol (POH).",[31,37,9,21,16,26,47,43],[57],"POH-TMZ",{"type":52,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Ipilimumab","Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. Cytotoxic T lymphocytes can recognize and destroy cancer cells.",[9,47],[63],"Yervoy",{"type":52,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Pembrolizumab","Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is given by slow injection into a vein.",[16,47],[69],"Keytruda",{"type":52,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"Nivolumab","Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer.",[21,47],[75],"Opdivo",{"type":52,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"Regorafenib","Regorafenib, sold under the brand name Stivarga among others, is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal and oncogenic receptor tyrosine kinase. Regorafenib shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition",[26,47],[81],"Stivagra",{"type":52,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"Carboplatin","Carboplatin, sold under the trade name Paraplatin among others, is a chemotherapy medication used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It is used by injection into a vein.",[31,47],[87],"Paraplatin",{"type":52,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"Paclitaxel","Paclitaxel, sold under the brand name Taxol among others, is a chemotherapy medication used to treat ovarian cancer, esophageal cancer, breast cancer, lung cancer, Kaposi's sarcoma, cervical cancer, and pancreatic cancer. It is administered by intravenous injection",[31,47],[93],"Taxol",{"type":52,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"FOLFIRI Protocol","FOLFIRI is a chemotherapy regimen for treatment of colorectal cancer. It is made up of the following drugs:\n\nFOL - folinic acid (leucovorin), a vitamin B derivative with multiple applications, which in this context increases the cytotoxicity of 5-fluorouracil; F - fluorouracil (5-FU), a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops synthesis; and IRI - irinotecan (Camptosar), a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating.",[37,47],[99],"Zaltrap",{"type":52,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"Bevacizumab","Bevacizumab, sold under the brand name Avastin among others, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma",[37,47],[105,106,107,108,109],"Avastin","Mvasi","Zirabev","Alymsys","Vegzelma",[111,115],{"name":112,"affiliation":113,"role":114},"Tom Chen, MD, PhD","NeOnc Technologies","STUDY_CHAIR",{"name":116,"affiliation":117,"role":118},"Josh Neman, PhD","NeOnc Technologies Holdings, Inc.","STUDY_DIRECTOR",[120,126],{"name":121,"role":122,"phone":123,"phoneExt":124,"email":125},"Christopher Beardmore","CONTACT","224 218 2408",null,"chris@anovaevidence.com",{"name":127,"role":122,"phone":123,"phoneExt":124,"email":128},"Chloe Richmond","chloe@anovaevidence.com",[130,152,167,181,194,210],{"facility":131,"status":132,"city":133,"state":134,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":143,"contacts":144},"Precision NextGen Oncology","RECRUITING","Beverly Hills","California","90212","United States","US",{"type":139,"coordinates":140},"Point",[141,142],-118.40036,34.07362,{"lat":142,"lon":141},[145,149],{"name":146,"role":122,"phone":147,"phoneExt":124,"email":148},"Francisco Capilla","(424) 777-0708","Franciscoc@nextgenonc.com",{"name":150,"role":151,"phone":124,"phoneExt":124,"email":124},"Kamlesh Sankhala, MD","PRINCIPAL_INVESTIGATOR",{"facility":153,"status":132,"city":154,"state":134,"zip":155,"country":136,"countryCode":137,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"OPN Healthcare, Inc","Glendale","91203",{"type":139,"coordinates":157},[158,159],-118.25508,34.14251,{"lat":159,"lon":158},[162,165],{"name":163,"role":122,"phone":124,"phoneExt":124,"email":164},"Heather Lyon","heatherl@opnhc.com",{"name":166,"role":151,"phone":124,"phoneExt":124,"email":124},"Vu Phan, MD",{"facility":168,"status":132,"city":169,"state":134,"zip":170,"country":136,"countryCode":137,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"University of Southern California","Los Angeles","90033",{"type":139,"coordinates":172},[173,174],-118.24368,34.05223,{"lat":174,"lon":173},[177],{"name":178,"role":122,"phone":179,"phoneExt":124,"email":180},"Sandy Tran","(323) 865-3980","Sandy.Tran@med.usc.edu",{"facility":182,"status":132,"city":183,"state":184,"zip":185,"country":136,"countryCode":137,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":139,"coordinates":187},[188,189],-86.78444,36.16589,{"lat":189,"lon":188},[192],{"name":193,"role":151,"phone":124,"phoneExt":124,"email":124},"Alexander Mohler, MD",{"facility":195,"status":132,"city":196,"state":197,"zip":198,"country":136,"countryCode":137,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Baylor, Scott and White Research Institute","Dallas","Texas","75246",{"type":139,"coordinates":200},[201,202],-96.80667,32.78306,{"lat":202,"lon":201},[205,208],{"name":206,"role":122,"phone":124,"phoneExt":124,"email":207},"Tarah Satterfield","Tarah.Satterfield@bswhealth.org",{"name":209,"role":151,"phone":124,"phoneExt":124,"email":124},"Divya Mella, MD",{"facility":211,"status":132,"city":212,"state":213,"zip":214,"country":136,"countryCode":137,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Northwest Medical Specialties","Tacoma","Washington","98405",{"type":139,"coordinates":216},[217,218],-122.44429,47.25288,{"lat":218,"lon":217},[221,224],{"name":222,"role":122,"phone":223,"phoneExt":124,"email":124},"Sue Quinsey","253-380-8173",{"name":225,"role":151,"phone":124,"phoneExt":124,"email":124},"Jorge Chaves, MD",{"type":227,"investigatorFullName":124,"investigatorTitle":124,"investigatorAffiliation":124,"oldNameTitle":124,"oldOrganization":124},"SPONSOR","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":237,"type":238},134,"ESTIMATED","INTERVENTIONAL",[241,242],"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.",[245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265],"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",[267,268,269,270,271,272,273,274,275,276,277,278],"Astrocytoma","IDH-mutant","Glioblastoma","IDH-wildtype","Brain Metastases","CNS Tumor","GBM","NeOnc","Anova","NEO212","NEO100","TMZ","2026-02-27",{"date":281,"type":282},"2026-03-02","ACTUAL",{"date":284,"type":282},"2023-11-01",{"date":286,"type":238},"2027-08-31",{"name":5,"class":6},6]