A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms

April 30, 2026 updated by: Incyte Corporation

A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • McGill University Jewish General Hospital
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hopital Maisonneuve-Rosemont, Montreal, Qc
  • France
      • Paris, France, 75010
        • Recruiting
        • Hospital Saint Louis
      • Villejuif, France, 94805
        • Recruiting
        • Institut Gustave Roussy
  • Germany
      • Aachen, Germany, D-52074
        • Recruiting
        • University Medical Center Rwth Aachen
      • Essen, Germany, 45147
        • Not yet recruiting
        • Universitatsklinikum Essen
      • Halle, Germany, 06120
        • Recruiting
        • Universitatsklinikum Halle (Saale)
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Aou Policlinico S. Orsola-Malpighi
      • Florence, Italy, 50134
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Careggi (AOUC)
      • Milan, Italy, 20122
        • Not yet recruiting
        • Fondazione Irccs Ca Granda Ospedale Maggiore
  • Norway
      • Bergen, Norway, N-5021
        • Recruiting
        • Haukeland University Hospital
      • Oslo, Norway, 00379
        • Recruiting
        • Oslo University Hospital
  • Switzerland
      • Bern, Switzerland, 03010
        • Recruiting
        • Inselspital - Universitaetsspital Bern
      • Zurich, Switzerland, 08091
        • Recruiting
        • Universitatsspital Zurich
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Not yet recruiting
        • Guys and St Thomas NHS Foundation Trust
      • Oxford, United Kingdom, OX4 6LB
        • Not yet recruiting
        • Genesiscare Oxford
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • The University of Alabama at Birmingham
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5008
        • Recruiting
        • University of Michigan
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Recruiting
        • Cornell Medical Center
      • New York, New York, United States, 10065
        • Recruiting
        • Sloan Kettering Institute for Cancer Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Health System
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Dose Escalation - with MF, PV or ET
INCB160058 will be administered at a protocol defined starting regimen to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF), polycythemia vera (PV) or essential thrombocythemia (ET) will enroll in this group.
Drug: INCB160058
Oral; Tablet
Experimental: Part 2 Dose Expansion - with MF, PV or ET
INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group.
Drug: INCB160058
Oral; Tablet
Experimental: Part 1 Dose Escalation - with MF SubOpt R
INCB160058 will be administered at a protocol defined starting regimen and will allow for the evaluation of INCB160058 in combination with a standard disease-directed therapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group.
Drug: INCB160058
Oral; Tablet
Drug: Standard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Experimental: Part 2 Dose Expansion - with MF SubOpt R
INCB160058 will be administered as an add-on therapy in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group.
Drug: INCB160058
Oral; Tablet
Drug: Standard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with Dose Limiting Toxicities (DLTs)
Time Frame: Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Up to 28 days
Number of participants with TEAEs leading to dose modification or discontinuation
Time Frame: Up to 2 years and 30 days
Number of participants with TEAEs leading to dose modification or discontinuation.
Up to 2 years and 30 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 2 years and 30 days
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Up to 2 years and 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
For participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF
Time Frame: Week 12 and 24 and then every 24 weeks up to 2 years
Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.
Week 12 and 24 and then every 24 weeks up to 2 years
For participants with MF: Percentage of participants achieving spleen volume reduction as defined in the protocol
Time Frame: Week 12 and Week 24
Defined as percentage of participants with a protocol defined Spleen Volume Reduction.
Week 12 and Week 24
For participants with PV: Response using revised IWG-MRT and ELN response criteria for PV
Time Frame: Week 12 and 24 and then every 24 weeks up to 2 years
Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.
Week 12 and 24 and then every 24 weeks up to 2 years
For participants with ET: Response using revised IWG-MRT and ELN response criteria for ET
Time Frame: Week 12 and 24 and then every 24 weeks up to 2 years
Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.
Week 12 and 24 and then every 24 weeks up to 2 years
For all participants: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS)
Time Frame: Week 24
Defined as the percentage of participants achieving ≥ 50% reduction from baseline of TSS.
Week 24
For all participants: Symptom improvement in TSS at Weeks 12 and 24 relative to baseline as measured by the Myeloproliferative Neoplasms Symptom Assessment Form (MPN-SAF) TSS.
Time Frame: Week 12 and Week 24
Defined as the proportion of participants who achieve a protocol defined reduction in Total Symptomatic Score (TSS) relative to baseline as measured by the MPN-SAF TSS.
Week 12 and Week 24
INCB160058 and a standard disease-directed therapy pharmacokinetic (PK) in Plasma
Time Frame: Up to Day 57
INCB160058 and the protocol defined standard disease-directed therapy concentration in plasma.
Up to Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Incyte Medical, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCB160058-101
  • 2024-520353-21-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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