[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658363":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":35,"studyPopulation":35,"armGroups":42,"interventions":58,"overallOfficials":35,"centralContacts":71,"locations":77,"responsibleParty":118,"collaborators":35,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":35,"enrollmentInfo":130,"targetDuration":35,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":94,"whyStopped":35,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Damora Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the safety and tolerability of DMR-001 & determine the MTD, RDE(s), and\u002For recommended Phase 2 dose(s) in participants with CALR-mutant MPNs, when administered as monotherapy or in combination with ruxolitinib","Incidence and severity of AEs and SAEs, including DLTs and AEs resulting in dose modification (interruption, reduction, or discontinuation)","Up to 672 days",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Evaluate preliminary clinical activity of DMR-001 as a monotherapy in participants with CALR-mutant ET","Objective response rate based on MPN specific response criteria",{"measure":18,"description":19,"timeFrame":12},"Evaluate preliminary clinical activity of DMR-001 as a monotherapy or in combination with ruxolitinib in participants with CALR-mutant MF","Established by looking at overall response rate based on MPN specific response criteria, protocol defined spleen volume reduction and protocol defined anemia response.",{"measure":21,"description":22,"timeFrame":12},"Pharmacokinetics parameter: Cmax of DMR-001 when administered as monotherapy or in combination with ruxolitinib","Maximum observed plasma concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib",{"measure":24,"description":25,"timeFrame":12},"Pharmacokinetics parameter: Tmax of DMR-001 when administered as monotherapy or in combination with ruxolitinib","Time to reach the maximum concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib",{"measure":27,"description":28,"timeFrame":12},"Pharmacokinetics parameter: AUC(0-t) of DMR-001 when administered as monotherapy or in combination with ruxolitinib","Area under the concentration-time curve up to the last measurable concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib",{"measure":30,"description":31,"timeFrame":12},"Pharmacokinetics parameter: t1\u002F2 of DMR-001 when administered as monotherapy or in combination with ruxolitinib","Apparent terminal phase disposition half-life of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib",{"measure":33,"description":34,"timeFrame":12},"Assess the immunogenicity of DMR-001","Incidence and persistence of anti-drug antibodies and neutralizing antibodies",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE",[43,49,53],{"label":44,"type":45,"description":46,"interventionNames":47},"Part 1: DMR-001 monotherapy dose escalation phase.","EXPERIMENTAL","DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the protocol defined starting dose and dosing schedule to identify the maximum tolerated dose and\u002For recommended dose(s) for expansion.",[48],"Drug: DMR-001",{"label":50,"type":45,"description":51,"interventionNames":52},"Part 2: DMR-001 monotherapy dose expansion phase.","DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the determined recommended dose(s) for expansion based on Part 1.",[48],{"label":54,"type":45,"description":55,"interventionNames":56},"Part 3: DMR-001 and ruxolitinib combination dose escalation followed by dose expansion.","DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the determined dose and regimen, but in combination with an oral tablet of ruxolitinib, a standard of care drug approved therapy for the treatment of MF.",[48,57],"Drug: Ruxolitinib",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":35},"DRUG","DMR-001","DMR-001 will be administered at protocol defined dose at a frequency of every 4 weeks.",[44,50,54],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Ruxolitinib","Ruxolitinib will be administered according to Prescribing Information\u002FSmPC.",[54],[69,70],"Jakafi","Jakavi",[72],{"name":73,"role":74,"phone":75,"phoneExt":35,"email":76},"Damora Therapeutics Medical Monitor","CONTACT","+1 782-281-9020","ClinicalTrials@Damoratx.com",[78,92,102,112],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":35},"Site AU08","NOT_YET_RECRUITING","Liverpool","New South Wales","2170","Australia","AU",{"type":87,"coordinates":88},"Point",[89,90],150.92588,-33.91938,{"lat":90,"lon":89},{"facility":93,"status":94,"city":95,"state":82,"zip":96,"country":84,"countryCode":85,"cosmosGeoPoint":97,"geoPoint":101,"contacts":35},"Site AU09","RECRUITING","Sydney","2050",{"type":87,"coordinates":98},[99,100],151.20732,-33.86785,{"lat":100,"lon":99},{"facility":103,"status":80,"city":104,"state":105,"zip":106,"country":84,"countryCode":85,"cosmosGeoPoint":107,"geoPoint":111,"contacts":35},"Site AU06","Melbourne","Victoria","2031",{"type":87,"coordinates":108},[109,110],144.96332,-37.814,{"lat":110,"lon":109},{"facility":113,"status":80,"city":104,"state":105,"zip":114,"country":84,"countryCode":85,"cosmosGeoPoint":115,"geoPoint":117,"contacts":35},"Site AU03","3004",{"type":87,"coordinates":116},[109,110],{"lat":110,"lon":109},{"type":119,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100658363","phase-1-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-mutant-calreticulin-targeted-antibodies-in-calr-mutant-myeloproliferative-neoplasms-100658363",false,"NCT07849231","A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms","A Phase 1\u002F1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Mutant Calreticulin Targeted Antibodies, Administered Alone or in Combination With Ruxolitinib, in Participants With CALR-mutant Myeloproliferative Neoplasms","CLARITY-101","Inclusion Criteria:\n\n* Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and the protocol.\n* Diagnosis\u002Fconfirmation of ET or MF as defined in the protocol.\n* Documented CALR exon-9 mutation.\n* Willingness to undergo bone marrow biopsy and aspiration per the Schedule of Assessments.\n\nExclusion Criteria:\n\n* Presence of any malignancy unless participant has been disease free for at least 2 years.\n* History of major bleeding or thrombosis within the last 3 months prior to study enrollment.\n* Prior hematopoietic stem cell transplantation or donor leukocyte infusion, or such transplantation or infusion is planned.\n* Participants with laboratory values exceeding protocol defined thresholds.\n* History of clinically significant or uncontrolled cardiac disease.\n* Active HBV, HCV or HIV.\n* Known hypersensitivity to DMR-001 or ruxolitinib or any of their components.\n\nOther protocol defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years",{"count":131,"type":132},250,"ESTIMATED","INTERVENTIONAL",[135],"PHASE1","This is a multi-center, open-label, Phase 1\u002F1b study designed to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of DMR-001 monotherapy in adult participants with CALR-mutated essential thrombocythemia (ET) and myelofibrosis (MF), and of DMR-001 in combination with ruxolitinib in participants with CALR-mutant MF.",[138],"Myeloproliferative Neoplasms (MPNs)",[140,141,142,143],"Myeloproliferative Neoplasms","Myelofibrosis","Essential Thrombocythemia","CALR mutation","2026-10-02",{"date":146,"type":147},"2026-10-07","ACTUAL",{"date":149,"type":132},"2026-09",{"date":151,"type":132},"2030-06",{"name":5,"class":6},4]