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INCA035784 for people with CALR‑mutated myeloproliferative neoplasms (myelofibrosis or essential thrombocythemia)

A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms

Phase 1 Interventional Incyte Corporation · NCT07008118

This trial tests whether INCA035784 is safe and tolerable in adults with CALR‑mutated myeloproliferative neoplasms who have already received prior therapies.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation Industry-sponsored
Locations26 sites (Phoenix, Arizona and 25 other locations)
Trial IDNCT07008118 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, open‑label study with a dose‑escalation part (Part 1a) followed by a dose‑expansion part (Part 1b) to define safety and tolerability of INCA035784. Eligible participants must have a documented CALR exon‑9 mutation and a confirmed diagnosis of myeloproliferative neoplasm meeting specified risk criteria for myelofibrosis or high‑risk essential thrombocythemia. Key enrollment requirements include prior therapy failure or intolerance, baseline blood‑count and coagulation limits, and no recent or planned stem cell transplant. Study visits will be at specialized US centers and will include safety labs, clinical exams, and monitoring for adverse events as dosing is escalated and expanded.

Who should consider this trial

Good fit: Adults (≥18) with a documented CALR exon‑9 mutation and confirmed myelofibrosis (DIPSS+ intermediate‑2/high risk with prior JAK inhibitor and measurable spleen) or high‑risk essential thrombocythemia with platelet counts >450×10⁹/L, who are resistant, refractory, intolerant, or have lost response to required prior therapies and meet performance‑status and lab criteria, are the intended candidates.

Not a fit: Patients without a CALR exon‑9 mutation, those with prior or planned stem cell transplant within six months, very low platelets or neutrophils, high blast counts (≥20%), or inability to attend study visits at the listed sites are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, INCA035784 could offer a new targeted treatment option for people with CALR‑mutated MPNs who have few effective therapies left.

How similar studies have performed: Existing therapies such as JAK inhibitors improve symptoms and spleen size in MPNs, but approaches specifically targeting CALR mutations remain early‑stage and have shown limited clinical success so far.

Eligibility criteria

Show full inclusion / exclusion 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 (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 this trial is running

Phoenix, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myeloproliferative NeoplasmsMyelofibrosisEssential thrombocythemiaCALR mutation
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.