A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: October 01, 2025
End Date: December 14, 2029
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
- 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 Criteria:
- 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.