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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Mayo Clinic-Florida
  Jacksonville, Florida, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• INCA036978 for people with myeloproliferative neoplasms

  This Phase 1 study will test whether INCA036978, given alone or with standard therapy, is safe and tolerable for adults with myeloproliferative neoplasms such as myelofibrosis, polycythemia vera, and essential thrombocythemia.

  Recruiting at 18 sites Phase 1 Incyte Corporation · Birmingham, Alabama and 53 other locations · NCT07441694

• MPN PROGRESSion Registry — tracking symptoms, treatments, and disease progression in people with MPNs.

  Track long-term symptoms, treatments, and disease progression in adults with myeloproliferative neoplasms to see how these conditions evolve over time.

  Recruiting at 2 sites MPN Research Foundation · Chicago, Illinois and 1 other locations · NCT07362225

• Combining Ivosidenib and Ruxolitinib for Advanced Myeloproliferative Neoplasms with IDH1 Mutation

  This study is testing if combining two medications, ivosidenib and ruxolitinib, can help people with advanced myeloproliferative neoplasms that have an IDH1 mutation feel better and improve their treatment outcomes.

  Recruiting at 2 sites Phase 1 University of Chicago · Chicago, Illinois and 1 other locations · NCT06291987

• Evaluating INCA033989 for treating myeloproliferative neoplasms

  This study is testing a new treatment called INCA033989, alone and with another drug, to see if it’s safe and effective for people with myeloproliferative neoplasms who have certain mutations.

  Recruiting at 13 sites Phase 1 Incyte Corporation · Duarte, California and 12 other locations · NCT06034002

• Hematopoietic stem cell transplant for blood cancers

  This study is testing two different ways of doing stem cell transplants for people with blood cancers to see which method works better and is safer.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT03314974

• Orally administered JBI-802 in certain blood cancers with high platelets

  This study tests whether taking JBI-802 by mouth can be safe and helpful for adults with essential thrombocythemia or related blood cancers that involve high platelet counts.

  Recruiting at 7 sites Phase 1/2 Jubilant Therapeutics Inc. · Sydney, New South Wales and 6 other locations · NCT07612280

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.