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New drug combo aims to tame rare blood cancers

NCT ID NCT05936359

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new drug called INCA033989, alone or with an existing drug ruxolitinib, in 225 people with myeloproliferative neoplasms (a group of blood cancers). The main goal is to check safety and find the best dose. Participants must have a specific genetic mutation (CALR) and be willing to have bone marrow tests.

What this could mean

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

Active substance
INCA033989 and ruxolitinib
What this could lead to
If successful, this could lead to a new treatment option for myeloproliferative neoplasms, potentially improving symptom control and reducing spleen size.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is not yet known if the drug works. Side effects and limited effectiveness are possible.

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

160 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Feb 2028

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: * Life expectancy \> 6 months. * Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease). * Existing documentation from a qualified local laboratory of CALR exon-9 mutation. * Participants with MF and ET as defined in the protocol. Exclusion Criteria: * Presence of any hematological malignancy other than ET, PMF, or post-ET MF. * Active invasive malignancy over the previous 2 years. * Active HBV/HCV, HIV. * History of clinically significant or uncontrolled cardiac disease. * Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned. * Laboratory values outside the Protocol-defined ranges. * Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment. * Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment. * Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. * For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study. 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

Contacts and locations

Locations

  • Aou Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Florence, 50134, Italy

  • Chu Nimes

    Nîmes, 30029, France

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Guys and St Thomas Nhs Foundation Trust

    London, SE1 9RT, United Kingdom

  • Hopital Maisonneuve-Rosemont, Montreal, Qc

    Montreal, Quebec, H1T 2M4, Canada

  • Hospital Saint Louis

    Paris, 75010, France

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Kagoshima University Hospital

    Kagoshima, 890-8520, Japan

  • Mie University Hospital

    Tsu, 514-0001, Japan

  • National Cancer Center Hospital East

    Chiba-ken, 277-0882, Japan

  • Nippon Medical School Hospital

    Tokyo, 113-8603, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586, Japan

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 03000, Australia

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9, Canada

  • Royal Adelaide Hospital

    Adelaide, South Australia, 05000, Australia

  • Royal Brisbane and Women'S Hospital

    Herston, Queensland, 04029, Australia

  • Sjaellands Universitetshospital

    Roskilde, 04000, Denmark

  • The Alfred Hospital

    Melbourne, Victoria, 03004, Australia

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BV, United Kingdom

  • Universitatsklinikum Halle (Saale)

    Halle, 06120, Germany

  • University Medical Center Rwth Aachen

    Aachen, 52074, Germany

  • University of Oxford

    Oxford, OX3 7LE, United Kingdom

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Vejle Hospital

    Vejle, 07100, Denmark

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