A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Launched by INCYTE CORPORATION · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called INCA035784 for people with myeloproliferative neoplasms (MPNs), which are conditions where the bone marrow makes too many blood cells. The main goal of the study is to see if this treatment is safe and how well it can be tolerated by participants. The trial is expected to begin soon, and anyone interested in participating must be at least 18 years old and have a specific genetic mutation (CALR exon-9). They should also have a confirmed diagnosis of MPN and have already tried at least one other treatment that didn’t work for them.

If you qualify for this study, you can expect to receive the new treatment and be closely monitored by the research team for any side effects or reactions. It's important to note that participants cannot have had major bleeding or blood clots recently, and they shouldn't be pregnant or planning to have a child during the trial. This study is a valuable opportunity to help researchers learn more about potential new treatments for MPNs, which could benefit future patients.

Gender

ALL

Eligibility criteria

• 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.