Tests INCA035784 safety in adults with myeloproliferative neoplasms
Tests INCA035784 for safety and tolerability in adults with myeloproliferative neoplasms.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
Key facts
- Where
- Bergamo, Florence, Milan, and Verona, ItalySee the 4 sites
- Phase
- Phase 1
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia MedicaFlorence, ItalyNot yet recruiting
- Fondazione IRCCS Ca' Granda Ospedale MaggioreMilan, ItalyNot yet recruiting
- Centro Ricerche Cliniche Di VeronaVerona, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT07008118
- Record updated
- 6 August 2026
- Original description
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.Read full original descriptionShow less
A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
Inclusion: Age 18 years or older at the time of signing the ICF; ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b); Documented CALR exon-9 mutation; Confirmed diagnosis of MPN according to the 2022 ICC criteria:; DIPSS+ intermediate-2/high-risk MF with prior JAKi, <20% blasts, and measurable spleen; High-risk ET with platelets >450×10⁹/L; 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); No prior stem cell transplant and none planned within 6 months; Minimum Laboratory Requirements:; Platelet count ≥50 × 10⁹/L; Absolute neutrophil count ≥1 × 10⁹/L; International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 × ULN; Total bilirubin <2 × ULN; Estimated creatinine clearance >45 or >30 mL/min (depending on study part).
Exclusion: Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months; Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment; 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); Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose; Other protocol-defined Inclusion/Exclusion Criteria may apply.