A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Inclusion Criteria

• •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)