[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651985":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":29,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":20,"studyType":47,"phases":48,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":62,"whyStopped":20,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":20},{"fullName":5,"class":6},"NanOlogy, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LSAM-Cisplatin 6 mg\u002FmL","EXPERIMENTAL","Phase 1 (Dose Escalation): Intratumoral infusion of LSAM-Cisplatin 6 mg\u002FmL using sequential, dose escalating cohorts.\n\nPhase 2 (Dose Expansion): Intratumoral infusion of LSAM-Cisplatin 6 mg\u002FmL at the recommended Phase 2 dose (RP2D).",[13],"Drug: LSAM-Cisplatin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","LSAM-Cisplatin","Participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), will receive a single intratumoral infusion of LSAM-Cisplatin 6 mg\u002FmL via MRI-guided delivery at an infusion rate of 5 µL\u002Fmin.\n\nPhase 1 (Dose Escalation): Participants will be enrolled sequentially into one of six dose levels. Volumes being delivered will range from 27 to 296 µL over a time period of 5 to 59 minutes.\n\nPhase 2 (Dose Expansion): Participants will receive LSAM-Cisplatin 6 mg\u002FmL at the recommended Phase 2 dose (RP2D) selected based on the safety and tolerability findings from the dose-escalation phase.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Shelagh Verco, PhD","CONTACT","805-704-1179","shelagh.verco@nanology.us",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[30],{"name":31,"class":32},"WEP Clinical","UNKNOWN","100651985","phase-1-targeted-lsam-cisplatin-infusion-in-gliomas-evaluation-of-response-100651985",false,"NCT07767110","Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response","Phase 1\u002F2a Study to Determine the Safety of Intratumoral Infusion of Large Surface Area Microparticle (LSAM)-Cisplatin in Participants With Diffuse Midline Glioma (DMG), Including Diffuse Intrinsic Pontine Glioma (DIPG)","TIGER-1","Inclusion Criteria:\n\n* Aged 3 to ≤ 21 years.\n* Diagnosis of diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), based on characteristic magnetic resonance imaging (MRI) findings and\u002For histopathologic confirmation.\n* Prior radiation treatment must have included focal radiation therapy per institutional standard of care and must have been initiated within 6 weeks of diagnosis.\n* At least 4 weeks, but no more than 12 weeks, post-completion of radiotherapy treatment.\n* A standard of care post-radiation magnetic resonance imaging (MRI) performed 4 to 6 weeks after radiation therapy is required for confirmation of eligibility.\n* Performance status \\[Karnofsky Performance Scale or Lansky Performance Score\\] within 14 days of Day 1 ≥ 60.\n* Absence of other significant medical condition.\n* A legal parent\u002Fguardian and\u002For participant must be able to understand and be willing to sign a written informed consent and\u002For assent document, as appropriate.\n\nExclusion Criteria:\n\n* Untreated symptomatic hydrocephalus at the time of consent, has metastatic or disseminated disease, or leptomeningeal disease.\n* Magnetic resonance imaging (MRI) findings that preclude stereotactic procedure.\n* Intercurrent illnesses or conditions which preclude participation: active systemic infections, autoimmune disease requiring systemic immunomodulation, active or uncontrolled seizure disorder, central nervous system (CNS) vasculopathy or aneurysms, Grade ≥3 cardiac dysfunction, Fridericia-corrected QT interval (QTcF) ≥470 ms.\n* Abnormal organ function:\n\n  * Renal insufficiency: glomerular filtration rate (GFR) ≤ 60 mL\u002Fmin\u002F1.73m² (with Schwartz equation)\n  * Hepatic dysfunction: aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of liver metastases; or bilirubin ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of Gilbert disease\n  * Bone marrow suppression:\n\n    * absolute neutrophil count (ANC) \\\u003C 1,000\u002FμL\n    * platelets \\\u003C 100,000\u002FμL\n  * Coagulopathy or international normalized ratio (INR) \\> 1.5\n* Receiving any anticoagulants or antiplatelet drugs; any drugs known to cause ototoxicity and nephrotoxicity; receiving any other tumor-directed therapy.\n* Known allergy or hypersensitivity to the study agent (including cisplatin and diluent components).\n* Female participants of childbearing potential must not be pregnant or breast-feeding.","ALL","3 Years","21 Years",{"count":45,"type":46},20,"ESTIMATED","INTERVENTIONAL",[49,50],"PHASE1","PHASE2","Open-label, dose-escalating, Phase 1\u002F2a trial of Large Surface Area Microparticle (LSAM)-Cisplatin to treat participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), via stereotactic infusion under intraoperative magnetic resonance imaging (MRI) guidance.",[53,54,55],"Diffuse Midline Glioma (DMG)","Diffuse Intrinsic Pontine Glioma (DIPG)","Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma",[57,58,59,60,61],"Diffuse Midline Glioma","Diffuse Intrinsic Pontine Glioma","H3 K27 Mutation","Pediatric Brain Tumor","Convection-enhanced delivery","NOT_YET_RECRUITING","2026-08-14",{"date":65,"type":66},"2026-08-18","ACTUAL",{"date":68,"type":46},"2026-12",{"date":70,"type":46},"2029-12",{"name":5,"class":6}]