RecruitingMyeloproliferative Neoplasms

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.

Sponsor: Incyte Corporation

✓ 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

✕ 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.