[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655134":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":22,"studyPopulation":22,"armGroups":54,"interventions":61,"overallOfficials":22,"centralContacts":67,"locations":72,"responsibleParty":106,"collaborators":22,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":22,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":22,"enrollmentInfo":117,"targetDuration":22,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":133,"whyStopped":22,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Orum Therapeutics USA, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":22},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Optimal Biological Dose(s) of ORM-1153","Identify the Dose-limiting Toxicities for each dose level tested and determine the OBD(s) of ORM-1153","Approximately 24 months",{"measure":14,"description":15,"timeFrame":12},"Incidence of Dose Limiting Toxicities (DLTs)","Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs",{"measure":17,"description":18,"timeFrame":12},"Incidence of Treatment Emergent Adverse Events (TEAEs)","Evaluate the safety and tolerability of ORM-1153 by identifying TEAEs",[20,24,26,28,30,32,34,36,38,40,42,44,46],{"measure":21,"description":22,"timeFrame":23},"Maximum Observed Serum Concentration (Cmax) of ORM-1153, total antibody and the payload",null,"Approximately 36 months",{"measure":25,"description":22,"timeFrame":23},"Time to Maximum Observed Serum Concentration (Tmax) of ORM-1153, total antibody and the payload",{"measure":27,"description":22,"timeFrame":23},"Area Under the Serum Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of ORM-1153, total antibody and the payload",{"measure":29,"description":22,"timeFrame":23},"Overall Response Rate (ORR) of ORM-1153 at various dose levels including OBD(s)",{"measure":31,"description":22,"timeFrame":23},"Duration of Response (DoR) of ORM-1153 at various dose levels including OBD(s)",{"measure":33,"description":22,"timeFrame":23},"Best Overall Response (BOR) of ORM-1153 at various dose levels including OBD(s)",{"measure":35,"description":22,"timeFrame":23},"CR with Partial (CRh) and Incomplete (CRi) Recovery of ORM-1153 at various dose levels including OBD(s)",{"measure":37,"description":22,"timeFrame":23},"Event Free Survival (EFS) of ORM-1153 at various dose levels including OBD(s)",{"measure":39,"description":22,"timeFrame":23},"Relapse Free Survival (RFS) of ORM-1153 at various dose levels including OBD(s)",{"measure":41,"description":22,"timeFrame":23},"Overall Survival (OS) of ORM-1153 at various dose levels including OBD(s)",{"measure":43,"description":22,"timeFrame":23},"Transition Rate to Allogeneic Hematopoietic Stem Cell Transplantation of ORM-1153 at various dose levels including OBD(s)",{"measure":45,"description":22,"timeFrame":23},"GSPT1 Protein Degradation and CD123 Receptor Occupancy of ORM-1153 at various dose levels including OBD(s)",{"measure":47,"description":22,"timeFrame":23},"Study the anti-drug antibodies against ORM-1153",{"allocation":49,"interventionModel":50,"interventionModelDescription":22,"primaryPurpose":51,"observationalModel":22,"timePerspective":22,"maskingInfo":52},"NA","SEQUENTIAL","TREATMENT",{"masking":53,"maskingDescription":22,"whoMasked":22},"NONE",[55],{"label":56,"type":57,"description":58,"interventionNames":59},"Part 1 Dose Escalation","EXPERIMENTAL","All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation.",[60],"Drug: ORM-1153",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":22},"DRUG","ORM-1153","Intravenous Infusion",[56],[68],{"name":5,"role":69,"phone":70,"phoneExt":22,"email":71},"CONTACT","617-714-9597","ClinicalTrials@orumrx.com",[73,91],{"facility":74,"status":22,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"START - Midwest","Grand Rapids","Michigan","49546","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-85.66809,42.96336,{"lat":84,"lon":83},[87],{"name":88,"role":69,"phone":89,"phoneExt":22,"email":90},"Andrew Sochacki, MD","616-389-6346","information@startresearch.com",{"facility":92,"status":22,"city":93,"state":94,"zip":95,"country":78,"countryCode":79,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":81,"coordinates":97},[98,99],-95.36327,29.76328,{"lat":99,"lon":98},[102],{"name":103,"role":69,"phone":104,"phoneExt":22,"email":105},"Abhishek Maiti, MD","877-632-6789","amaiti@mdanderson.org",{"type":107,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100655134","phase-1-study-of-orm-1153-in-acute-myeloid-leukemia-aml-with-cd123-expression-100655134",false,"NCT07809906","Study of ORM-1153 in Acute Myeloid Leukemia (AML) With CD123 Expression","Phase 1 First-in-Human Multi-Region Clinical Trial of ORM-1153 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Other Hematological Malignancies With CD123 Expression","Inclusion Criteria:\n\n* Adults ≥18 years of age (or ≥19 years of age according to local regulatory guidelines) at the time of signature of the informed consent form.\n* Documented diagnosis of relapsed or refractory AML with any detectable level of CD123 as evaluated by local assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Adequate organ and coagulation function.\n\nExclusion Criteria:\n\n* Diagnosed with Acute Promyelocytic Leukemia.\n* Systemic antineoplastic agent therapy given within 14 days or 5 half-lives prior to the first dose of ORM-1153 (whichever is shorter).\n* Hematopoietic Stem Cell Transplantation within 3 months of the first dose of ORM-1153.\n* Total White Blood Cell count \\>25,000\u002FµL.","ALL","18 Years",{"count":118,"type":119},42,"ESTIMATED","INTERVENTIONAL",[122],"PHASE1","The goal of this Phase 1 clinical trial is to understand whether a new experimental treatment, called ORM-1153, will be a safe and possibly effective treatment option for participants with blood cancers such as Acute Myeloid Leukemia (AML) which have a particular protein (called Cluster of Differentiation 123 or CD123) on the cancer cell's surface. Phase 1 studies are designed to find a safe and effective dose.\n\nParticipants will be receiving ORM-1153 at the defined study frequency as an infusion into the vein. They will need to visit the clinic frequently during the first few months of treatment.",[125],"CD123+ Acute Myeloid Leukemia",[127,128,129,130,131,132],"Antibody Drug Conjugate","Protein-Degradation","GSPT1","CD123","AML","Hematologic Malignancies","NOT_YET_RECRUITING","2026-09-08",{"date":136,"type":137},"2026-09-09","ACTUAL",{"date":139,"type":119},"2026-12",{"date":141,"type":119},"2029-12",{"name":5,"class":6},2]