RecruitingPhase 1NCT07008118
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms
Sponsor
Incyte Corporation
Enrollment
120 participants
Start Date
Oct 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
Eligibility
Min Age: 18 Years
Inclusion Criteria15
- 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 Criteria4
- 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.
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Interventions
DRUGINCA035784
INCA035784 will be administered at the assigned dose in the dose escalation part and at the protocol defined dose in the dose expansion part.
Locations(26)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07008118
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