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New hope for rare blood cancers? early trial begins

NCT ID NCT06313593

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called INCB160058 in adults with myeloproliferative neoplasms, a group of rare blood cancers. The main goal is to check the drug's safety and how the body processes it. About 186 participants will receive the drug to find the right dose and watch for side effects.

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

37 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Oct 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: * Age ≥ 18 years * MF: * Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment. * For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator. * PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment. * ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment. * Life expectancy \> 6 months. * Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease). * Existing documentation of JAK2V617F mutation from a qualified local laboratory. Exclusion Criteria: * Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET. * Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment. * Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation. * Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned * Active invasive malignancy. * Significant concurrent, uncontrolled medical condition. * Acute or chronic HBV, active HCV or known HIV. * Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. * Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera 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

  • Cornell Medical Center

    New York, New York, 10021, United States

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Genesiscare Oxford

    Oxford, OX4 6LB, United Kingdom

  • Guys and St Thomas Nhs Foundation Trust

    London, SE1 9RT, United Kingdom

  • Haukeland University Hospital

    Bergen, N-5021, Norway

  • Hopital Maisonneuve-Rosemont, Montreal, Qc

    Montreal, Quebec, H1T 2M4, Canada

  • Hospital Saint Louis

    Paris, 75010, France

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029, United States

  • Inselspital - Universitaetsspital Bern

    Bern, 03010, Switzerland

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • McGill University Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Md Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Oslo University Hospital

    Oslo, 00379, Norway

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9, Canada

  • Sloan Kettering Institute For Cancer Research

    New York, New York, 10065, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • The University of Alabama At Birmingham

    Birmingham, Alabama, 35249, United States

  • The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • Universitatsklinikum Essen

    Essen, 45147, Germany

  • Universitatsklinikum Halle (Saale)

    Halle, 06120, Germany

  • Universitatsspital Zurich

    Zurich, 08091, Switzerland

  • University Medical Center Rwth Aachen

    Aachen, D-52074, Germany

  • University of Michigan

    Ann Arbor, Michigan, 48109-5008, United States

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

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