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New drug INCA035784 enters human testing for rare blood cancers

NCT ID NCT07008118

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 6 times

Summary

This early-stage trial tests a new drug, INCA035784, in 120 adults with myeloproliferative neoplasms (a group of blood cancers). The main goal is to check safety and find the right dose. Participants must have a specific genetic mutation (CALR) and have tried other treatments before.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INCA035784
What this could lead to
If successful, this could point toward a new treatment option for certain blood cancers called myeloproliferative neoplasms.
What could go wrong
This is an early Phase 1 trial focused on safety, not effectiveness. It is small and may not lead to a working treatment. Side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

essential thrombocythemia myelofibrosis Myeloproliferative Disorders myeloproliferative neoplasm primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myeloproliferative neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • Centro Ricerche Cliniche Di Verona

    NOT_YET_RECRUITING

    Verona, 37134, Italy

  • Cliniques Universitaires Saint-Luc

    NOT_YET_RECRUITING

    Brussels, 01200, Belgium

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    NOT_YET_RECRUITING

    Milan, 20122, Italy

  • Huntsman Cancer Institute At University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine At Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, 06009, Australia

  • Macquarie University Hospital

    RECRUITING

    Sydney, New South Wales, 02109, Australia

  • Mayo Clinic Hospital

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic-Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 05000, Australia

  • South Austin Medical Center

    RECRUITING

    Austin, Texas, 78704, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 03004, Australia

  • Universitaetsklinikum Dresden

    NOT_YET_RECRUITING

    Dresden, 01307, Germany

  • Universitair Ziekenhuis Gent

    NOT_YET_RECRUITING

    Ghent, 09000, Belgium

  • Universitaire Ziekenhuizen Leuven

    NOT_YET_RECRUITING

    Leuven, 03000, Belgium

  • Universitatsklinikum Halle (Saale)

    NOT_YET_RECRUITING

    Halle, 06120, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of North Carolina At Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center Blood

    RECRUITING

    Dallas, Texas, 75235, United States

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