Myeloproliferative NeoplasmsPhase 1NCT06313593
A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
A Phase 1 study testing INCB160058 and Standard disease-directed therapy in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 30 sites in 8 countries.
Trial summary
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasms
- What is being tested?
- INCB160058 and Standard disease-directed therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 8 Aug 2024to 9 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109-5008
The University of Alabama At Birmingham
Birmingham, Alabama, 35249
Northwestern University
Chicago, Illinois, 60611
The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center
Fairway, Kansas, 66205
Md Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Cornell Medical Center
New York, New York, 10021
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
Sloan Kettering Institute For Cancer Research
New York, New York, 10065
Stanford University
Palo Alto, California, 94304
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Moffitt Cancer Center
Tampa, Florida, 33612
Canada3 sites
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal, Quebec, H1T 2M4
McGill University Jewish General Hospital
Montreal, Quebec, H3T 1E2
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Germany3 sites
University Medical Center Rwth Aachen
Aachen, D-52074
Universitatsklinikum Essen
Essen, 45147
Universitatsklinikum Halle (Saale)
Halle, 06120
Italy3 sites
Aou Policlinico S. Orsola-Malpighi
Bologna, 40138
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, 50134
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122
France2 sites
Hospital Saint Louis
Paris, 75010
Institut Gustave Roussy
Villejuif, 94805
Norway2 sites
Haukeland University Hospital
Bergen, N-5021
Oslo University Hospital
Oslo, 00379
Switzerland2 sites
Inselspital - Universitaetsspital Bern
Bern, 03010
Universitatsspital Zurich
Zurich, 08091
United Kingdom2 sites
Guys and St Thomas Nhs Foundation Trust
London, SE1 9RT
Genesiscare Oxford
Oxford, OX4 6LB
About this study
Official title: 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.
- Conditions
- Myeloproliferative Neoplasms
- Being tested
- INCB160058, Standard disease-directed therapy
- Keywords
- Myeloproliferative Neoplasms, INCB160058, Myelofibrosis
- Medical subject headings
- Myeloproliferative Disorders, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB160058Drug
Oral; Tablet
Standard disease-directed therapyDrug
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation - with MF, PV or ET | Experimental | 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. Receives: Drug: INCB160058 |
| Part 1 Dose Escalation - with MF SubOpt R | Experimental | 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. Receives: Drug: INCB160058; Drug: Standard disease-directed therapy |
| Part 2 Dose Expansion - with MF, PV or ET | Experimental | INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group. Receives: Drug: INCB160058 |
| Part 2 Dose Expansion - with MF SubOpt R | Experimental | 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. Receives: Drug: INCB160058; Drug: Standard disease-directed therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Measured: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to 2 years and 30 days
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Measured: Up to 2 years and 30 days
Secondary outcomes (7)
INCB160058 and a standard disease-directed therapy pharmacokinetic (PK) in Plasma
INCB160058 and the protocol defined standard disease-directed therapy concentration in plasma.
Measured: Up to Day 57
For participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF
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.
Measured: 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
Defined as percentage of participants with a protocol defined Spleen Volume Reduction.
Measured: Week 12 and Week 24
For participants with PV: Response using revised IWG-MRT and ELN response criteria for PV
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.
Measured: 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
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.
Measured: 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)
Defined as the percentage of participants achieving ≥ 50% reduction from baseline of TSS.
Measured: 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.
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.
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start8 Aug 2024
- Primary completion9 Oct 2028 (estimated)
- Study completion9 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313593
- Sponsor's protocol ID
- INCB160058-101
- Other IDs
- 2024-520353-21-00
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT06313593
- Acronym / sponsor ID
- INCB160058-101
- Conditions
- Myeloproliferative Neoplasms
- Keywords
- Myeloproliferative Neoplasms, INCB160058, Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 9 Oct 2028 (estimated)
- Study completion
- 9 Oct 2028 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation - with MF, PV or ET | Experimental | Drug: INCB160058INCB160058 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. |
| Part 1 Dose Escalation - with MF SubOpt R | Experimental | Drug: INCB160058, Drug: Standard disease-directed therapyINCB160058 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. |
| Part 2 Dose Expansion - with MF, PV or ET | Experimental | Drug: INCB160058INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group. |
| Part 2 Dose Expansion - with MF SubOpt R | Experimental | Drug: INCB160058, Drug: Standard disease-directed therapyINCB160058 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- MF:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB160058Oral; Tablet | Drug | Part 1 Dose Escalation - with MF SubOpt R, Part 1 Dose Escalation - with MF, PV or ET, Part 2 Dose Expansion - with MF SubOpt R, Part 2 Dose Expansion - with MF, PV or ET |
| Standard disease-directed therapyA standard disease-directed therapy will be administered according to Prescribing Information/SmPC. | Drug | Part 1 Dose Escalation - with MF SubOpt R, Part 2 Dose Expansion - with MF SubOpt R |
Primary outcome
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.
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.
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.
7 secondary outcomes
INCB160058 and a standard disease-directed therapy pharmacokinetic (PK) in Plasma
Time frame: Up to Day 57
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
For participants with MF: Percentage of participants achieving spleen volume reduction as defined in the protocol
Time frame: 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
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
For all participants: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative NeoplasmsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical study director
Incyte Corporation
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB160058 and Standard disease-directed therapy in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, Germany, Italy, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.