[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620430":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":70,"collaborators":25,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":25,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":25,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Lantheus Medical Imaging","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1- Escalating doses of LNTH-2403 administered once every 8 weeks","EXPERIMENTAL","Phase 1 will evaluate escalating doses of LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data.",[13],"Drug: LNTH2403 Phase 1 dose",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 2 will evaluate LNTH-2403 as a single agent at the recommended phase 2 dose","Phase 2 will evaluate LNTH-2403 as a single agent in participants with R\u002FR osteosarcoma at the recommended phase 2 dose (RP2D).",[18],"Drug: Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","LNTH2403 Phase 1 dose","LNTH-2403 administered once every 8 weeks, with the potential to explore other dosing schedules based on observed radiation dosimetry and PK parameters and safety and tolerability data.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Phase 2; LNTH2403 a single agent recommended phase 2 dose (RP2D).","Once the RP2D is selected, phase 2 will commence",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Kerri Sforzo","CONTACT","978-671-8886","clinicaltrials@lantheus.com",[37,56],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"UCLA","RECRUITING","Los Angeles","California","90095","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-118.24368,34.05223,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":54,"phoneExt":25,"email":55},"Gregory Ellis","(424) 320-1853","GEllis@mednet.ucla.edu",{"facility":57,"status":39,"city":58,"state":59,"zip":60,"country":43,"countryCode":44,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Dana Farber Cancer Institute","Boston","Massachusetts","02115",{"type":46,"coordinates":62},[63,64],-71.05977,42.35843,{"lat":64,"lon":63},[67],{"name":68,"role":33,"phone":69,"phoneExt":25,"email":25},"Sarcoma Program Research Nurse","877-DF-TRIAL (877-388-7425)",{"type":71,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100620430","phase-1-lu-targo-177lu-targeted-osteosarcoma-therapy-100620430",false,"NCT07357519","Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)","A Phase 1\u002F2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, -Radiation Dosimetry, and Preliminary Anti-Neoplastic Activity of LNTH-2403, a LRRC15-targeted 177Lutetium-labeled Monoclonal Antibody, in Participants With Relapsed \u002F Refractory Osteosarcoma","Inclusion Criteria: Participants must meet all the following criteria to be enrolled in the study\n\n1. Histopathologic documented diagnosis of R\u002FR osteosarcoma\n2. Must have disease characterized by at least one of the following (Participants meeting only (b.), only (c.), or only (b. and c.) must be discussed with and receive written approval from the Sponsor to qualify).\n\n   1. Measurable as defined in RECIST 1.1\n   2. Evaluable non-measurable disease as per RECIST 1.1\n   3. Bone only without a soft tissue component: must be 18F-FDG-PET avid and evaluable by serial 18F-FDG-PET imaging studies.\n3. Age: a. First Cohort in Phase 1: ≥ 18 years-of-age at the time of signature of the main study ICF. b. Second and subsequent cohorts, in Phase 1 and all participants in Phase 2: ≥12years-of-age at the time of signature of the main ICF.\n4. Performance Status:\n\n   1. Eastern Cooperative Oncology Group (ECOG) Performance Score (PS): 0 - 2\n   2. Lansky PS ≥ 50.\n5. Body weight: ≥ 30 kg.\n6. Tumor biopsies; Fresh or Archival\n7. Progression following at least one course of chemotherapy, which includes neoadjuvant \u002F perioperative systemic therapy.\n8. All adverse events (AEs) related to prior therapies (chemotherapy \u002F systemic therapies, radiation, surgery) must have resolved to Grade 1 or baseline\n9. Organ Function\n10. Pregnancy Women of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test result at screening\n11. Contraception- Male participants with a WOCBP partner must use 2 forms of acceptable contraception\n12. Written informed consent and\u002For assent must be obtained according to local guidelines and signed and dated by the participant, parent, and\u002For legal guardian prior to the performance of any study-specific procedures, sampling, or analyses\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study\n\n1. Known allergies, hypersensitivity, or intolerance to LNTH-2403 and\u002For its excipients\n2. Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the participant's safety, compliance with the study, or otherwise impair the assessment of study results\n3. Concurrent treatment with any other anti-neoplastic agents, including localized radiation therapy\n4. Known active infection\n5. Participation in an interventional study of another investigational agent\n6. Prior therapies or diagnostics\n7. Active prior or concurrent malignancy: immunoglobulin),\n8. Known active liver disease from any cause, Hepatitis A Virus\n9. Known to be human immunodeficiency virus (HIV) positive\n10. Clinically relevant cardiovascular disease\n11. Receipt of live vaccine within the 30 days prior to the first dose o\n12. A female participant who is pregnant or breastfeeding\n13. Major surgical procedure within 28 days of the first dose of LNTH-2403.\n14. Participant is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions","ALL","12 Years",{"count":82,"type":83},55,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","This is a multi-center, non-randomized, open-label, dosimetry and dose-escalation, cohort-expansion study of LNTH-2403 administered to subjects with relapsed \u002F refractory (R\u002FR) osteosarcoma. This study consists of 2 phases: (1) a dosimetry and dose escalation phase; and (2) a cohort expansion phase.",[90],"Relapsed \u002F Refractory Osteosarcoma","2026-04-27",{"date":93,"type":94},"2026-05-01","ACTUAL",{"date":96,"type":94},"2026-02-03",{"date":98,"type":83},"2032-05",{"name":5,"class":6},2]