[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lantheus Medical Imaging\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27],"Relapsed \u002F Refractory Osteosarcoma","RECRUITING","2026-04-27",{"date":31,"type":32},"2026-05-01","ACTUAL",{"date":34,"type":32},"2026-02-03",{"date":36,"type":20},"2032-05",{"name":38,"class":39},"Lantheus Medical Imaging","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":60,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100539059","phase-1-64cu-lnth-1363s-in-patients-with-sarcoma-or-gastrointestinal-tract-cancer-100539059","NCT06298916","64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer","A Phase 1\u002F2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET\u002FCT Imaging Agent) in Patients With Sarcoma or Gastrointestinal Tract Cancer (PHANTOM Trial)","PHANTOM","Inclusion Criteria: Part 1\n\nPatients are eligible to be included in the study only if all of the following criteria apply:\n\n1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \\\u003C18 years must weigh at least 55 kg.\n2. Patients with suspected FAP-expressing metastatic sarcoma.\n3. Patients must have histological, pathological, and\u002For cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).\n4. Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.\n5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft Gault equation).\n6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.\n7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.\n\nInclusion Criteria: Part 2\n\n1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \\\u003C18 years must weigh at least 55 kg.\n2. Patients must have histological, pathological, and\u002For cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer.\n3. Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging).\n4. Patients must be willing to consent to provide sufficient and adequate tumor tissue samples (formalin fixed, paraffin embedded sample), from their planned surgery after participating in study imaging.\n5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft Gault equation).\n6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.\n7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.\n\nExclusion Criteria: Part 1\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.\n2. Known pregnancy or breastfeeding.\n3. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.\n4. Patients participating in another clinical trial at the time of screening for this study.\n5. Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.\n6. Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.\n7. History of QT\u002FQTc interval prolongation, a marked baseline QT\u002FQTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \\> 450 milliseconds) or taking medication known to cause QT\u002FQTc prolongation.\n8. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).\n\nExclusion Criteria: Part 2\n\n1. Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration.\n2. Evidence of metastatic or advanced, inoperable disease.\n3. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.\n4. Known pregnancy or breastfeeding.\n5. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.\n6. Patients participating in another clinical trial at the time of screening for this study.\n7. Has undergone or plans to undergo PET or SPECT imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.\n8. History of QT\u002FQTc interval prolongation, a marked baseline QT\u002FQTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \\> 450 milliseconds) or taking drugs known to cause QT\u002FQTc prolongation.\n9. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome","15 Years",{"count":50,"type":20},26,[23,24],"This is a multicenter, open-label, prospective Phase 1\u002F2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).",[54,55,56,57,58,59],"Metastatic Sarcoma","Esophageal Cancer","Gastric Cancer","Pancreatic Cancer","Colorectal Cancer","Sarcoma",[61,62,63],"FAPi","Imaging","64Cu-LNTH-1363S","2025-08-06",{"date":66,"type":32},"2025-08-12",{"date":68,"type":20},"2025-08",{"date":70,"type":20},"2026-04",{"name":38,"class":39},5,""]