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Study of INCA035784 for Myeloproliferative Neoplasms

This study is testing a drug called INCA035784 in people with myeloproliferative neoplasms (MPNs), which are a group of blood cancers. The main goal is to see how safe INCA035784 is and how well people tolerate it. Researchers will be looking for any side effects and how often they occur. You might be able to join if you are 18 or older, have a specific gene change called a CALR exon-9 mutation, and have a confirmed diagnosis of MPN, such as certain types of myelofibrosis (MF) or essential thrombocythemia (ET). The study plans to enroll about 120 participants. The current status of the study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 120 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events for up to approximately 2 years and 90 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07008118

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Recruiting
PHASE1Ages 18+InterventionalTreatment
Incyte Corporation
~120 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:INCA035784

At a glance

Recruiting sites
16 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Dose Limiting Toxicities (DLTs)
Measured over Up to 28 days
+2 more outcomes measured

Conditions

Myeloproliferative Neoplasms

Explore related trials

Essential ThrombocythemiaMyelofibrosisCALR Gene

Where it's being run

26 sites across 18 states
Italy4
Belgium3
Germany3
Texas2
Arizona1
California1
Colorado1
Florida1

Study leadership

  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation

Who to contact

Incyte Corporation Call Center (US)
[email protected]
1.855.463.3463
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with Dose Limiting Toxicities (DLTs)Up to 28 days

    Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

  • Number of participants with Treatment-emergent Adverse Events (TEAEs)Up to approximately 2 years and 90 days

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug.

  • Number of participants with TEAEs leading to treatment interruption, discontinuation, or delayUp to approximately 2 years and 90 days

    Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay.