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Participants with myeloproliferative neoplasm (MPN) will enroll in this group.",[13],"Drug: INCA035784",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1b: Dose expansion","INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","INCA035784","INCA035784 will be administered at the assigned dose in the dose escalation part and at the protocol defined dose in the dose expansion part.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Incyte Medical Monitor","STUDY_DIRECTOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Incyte Corporation Call Center (ex-US)","+800 00027423","eumedinfo@incyte.com",[40,53,64,74,84,94,104,113,123,133,142,152,162,173,183,193,203,213,222,231,241,250,259,269,278,287],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":24},"Mayo Clinic 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Patologia Medica","Florence","50134",{"type":48,"coordinates":274},[275,276],11.24626,43.77925,{"lat":276,"lon":275},{"facility":279,"status":42,"city":280,"state":24,"zip":281,"country":263,"cosmosGeoPoint":282,"geoPoint":286,"contacts":24},"Fondazione Irccs Ca Granda Ospedale Maggiore","Milan","20122",{"type":48,"coordinates":283},[284,285],9.18951,45.46427,{"lat":285,"lon":284},{"facility":288,"status":42,"city":289,"state":24,"zip":290,"country":263,"cosmosGeoPoint":291,"geoPoint":295,"contacts":24},"Centro Ricerche Cliniche Di Verona","Verona","37134",{"type":48,"coordinates":292},[293,294],10.9938,45.43854,{"lat":294,"lon":293},{"type":297,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100593567",false,"NCT07008118","A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Age 18 years or older at the time of signing the ICF\n* ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)\n* Documented CALR exon-9 mutation\n* Confirmed diagnosis of MPN according to the 2022 ICC criteria:\n\n  * DIPSS+ intermediate-2\u002Fhigh-risk MF with prior JAKi, \\\u003C20% blasts, and measurable spleen\n  * High-risk ET with platelets \\>450×10⁹\u002FL\n* Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET (unless only a single standard-of-care option is approved in the participating country)\n* No prior stem cell transplant and none planned within 6 months\n* Minimum Laboratory Requirements:\n\n  * Platelet count ≥50 × 10⁹\u002FL\n  * Absolute neutrophil count ≥1 × 10⁹\u002FL\n  * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 × ULN\n  * Total bilirubin \\\u003C2 × ULN\n  * Estimated creatinine clearance \\>45 or \\>30 mL\u002Fmin (depending on study part)\n\nExclusion Criteria:\n\n* Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months\n* Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment\n* Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate cancer)\n* Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years",{"count":307,"type":308},120,"ESTIMATED","INTERVENTIONAL",[311],"PHASE1","This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.",[314],"Myeloproliferative Neoplasms",[314,316,317,318],"Myelofibrosis","Essential thrombocythemia","CALR mutation","2026-04-02",{"date":321,"type":322},"2026-04-06","ACTUAL",{"date":324,"type":322},"2025-10-01",{"date":326,"type":308},"2029-12-14",{"name":5,"class":6},26]