NCT07008118 · Incyte Corporation
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
What this study is about
This study is being conducted to evaluate the safety and how well patients handle the treatment of INCA035784 in participants with myeloproliferative neoplasms.
View original scientific description
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
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.
Where
- Phoenix, Arizona
- Palo Alto, California
- Denver, Colorado
- Jacksonville, Florida
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- New York, New York
- Chapel Hill, North Carolina
- Austin, Texas
- Dallas, Texas
- Salt Lake City, Utah
And 1 more location — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations