Myeloproliferative NeoplasmsPhase 1NCT07441694
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
A Phase 1 study testing INCA036978 and Standard disease-directed therapy in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 54 sites in 11 countries.
Trial summary
This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy. 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?
- INCA036978 and Standard disease-directed therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 54 sitesin 11 countries
- Study dates
- 11 May 2026to 24 May 2030
- 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
- Life expectancy > 6 months.
- Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
- Participants with MF, PV and ET as defined in the protocol.
Who cannot join
- Presence of any hematological malignancy other than MF, PV, or ET.
- Malignancy within the last 3 years prior to enrollment.
- Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
- Clinically significant or uncontrolled cardiac disease.
- Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
- Laboratory values outside the Protocol-defined ranges.
Show all 11Show fewer
- Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.
- Presence of chronic or current active infectious disease requiring systemic treatment.
- Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.
- Prior radiation therapy within 28 days before the first dose of study treatment.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
54 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
54 sites in 11 countries
United States23 sites, 23 recruiting
- Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
- Not yet recruiting
John Hopkins Hospital
Baltimore, Maryland, 21287
- Not yet recruiting
University of Alabama At Birmingham
Birmingham, Alabama, 35233
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514
- Not yet recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Ohio State University
Columbus, Ohio, 43210
- Not yet recruiting
Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy
Durham, North Carolina, 27705
- Not yet recruiting
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
City of Hope-Lennar Foundation Cancer Center
Irvine, California, 92618
- Not yet recruiting
Usc Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Not yet recruiting
UCLA Medical Hematology & Oncology
Los Angeles, California, 90095
- Not yet recruiting
University of Miami
Miami, Florida, 33136
- Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Tristar Bmt/Tcto
Nashville, Tennessee, 37203
- Not yet recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
- Not yet recruiting
Mount Sinai School of Medicine
New York, New York, 10029
- Not yet recruiting
Weill Cornell Medicine
New York, New York, 10065
- Not yet recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
- Not yet recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Australia5 sites, 5 recruiting
- Recruiting
Icon Cancer Centre
Auchenflower, Queensland, 04066
- Recruiting
Concord General Repatriation Hospital
Concord, New South Wales, 02139
- Recruiting
Epworth Health Care
East Melbourne, Victoria, 03002
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 06009
- Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 02065
Germany5 sites, 5 recruiting
- Recruiting
University Medical Center Rwth Aachen
Aachen, D-52074
- Not yet recruiting
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 10117
- Recruiting
Universitatklinikum Freiburg
Freiburg im Breisgau, 79106
- Not yet recruiting
Universitatsklinikum Halle (Saale)
Halle, 06120
- Not yet recruiting
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, 55131
Italy4 sites, 4 recruiting
- Not yet recruiting
Aou Policlinico S. Orsola-Malpighi
Bologna, 40138
- Not yet recruiting
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
- Not yet recruiting
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, 00168
- Not yet recruiting
Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
Udine, 33100
France3 sites, 3 recruiting
- Recruiting
Francois-Xavier
Bordeaux, 33076
- Recruiting
Hospital Saint Louis
Paris, 75010
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
- Not yet recruiting
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, SE1 9RT
- Not yet recruiting
Nottingham University Hospitals
Nottingham, NG5 1PB
- Recruiting
University of Oxford
Oxford, OX3 7LE
Belgium2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire (Chu) de Liege
Liège, 04000
- Not yet recruiting
AZ DELTA
Roeselare, 08800
Canada2 sites, 2 recruiting
- Not yet recruiting
McGill University Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Japan2 sites, 2 recruiting
- Not yet recruiting
National Cancer Center Hospital East
Kashiwa Chiba, 277-0882
- Not yet recruiting
Ehime University Hospital
Toon, Ehime, 791-0204
South Korea2 sites, 2 recruiting
- Not yet recruiting
Seoul National University Hospital
Jongno-gu, Seoul, 03080
- Not yet recruiting
The Catholic University of Korea Seoul St. Mary'S Hospital
Seocho-gu, Seoul, 06591
About this study
Official title: A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.
- Conditions
- Myeloproliferative Neoplasms
- Being tested
- INCA036978, Standard disease-directed therapy
- Keywords
- Myeloproliferative Neoplasms, Myelofibrosis, Essential thrombocythemia, Polycythemia Vera
- Medical subject headings
- Myeloproliferative Disorders, Primary Myelofibrosis, Thrombocythemia, Essential, Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA036978Drug
INCA036978 will be administered at protocol defined dose.
Standard disease-directed therapyDrug
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: Dose Escalation | Experimental | INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s). Receives: Drug: INCA036978 |
| Part 1b: Dose Escalation | Experimental | INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s). Receives: Drug: INCA036978; Drug: Standard disease-directed therapy |
| Part 2a: Dose Expansion | Experimental | INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1 Receives: Drug: INCA036978 |
| Part 2b: Dose Expansion | Experimental | INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. Receives: Drug: INCA036978; 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 (DLT)s in Part 1
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 AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.
Measured: Up to approximately 2 years
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.
Measured: Up to approximately 2 years
Secondary outcomes (13)
Pharmacokinetics Parameter: Cmax of INCA036978
Defined as maximum observed plasma concentration of INCA036978.
Measured: Up to approximately 2 years
Pharmacokinetics Parameter: Tmax of INCA036978
Defined as the time to reach the maximum plasma concentration of INCA036978.
Measured: Up to approximately 2 years
Pharmacokinetics Parameter: Cmax,ss of INCA036978
Defined as the maximum observed plasma concentration at steady state of INCA036978.
Measured: Up to approximately 2 years
Pharmacokinetics Parameter: Cmin,ss of INCA036978
Defined as the minimum observed plasma concentration at steady state of INCA036978.
Measured: Up to approximately 2 years
Pharmacokinetics Parameter: AUC(0-t) of INCA036978
Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036978.
Measured: Up to approximately 2 years
Pharmacokinetics Parameter: AUC 0-∞ of INCA036978
Defined as the area under the concentration-time curve from 0 to infinity of INCA036978.
Measured: Up to approximately 2 years
Pharmacokinetics Parameter: CL/F of INCA036978
Defined as the apparent clearance of INCA036978.
Measured: Up to approximately 2 years
Pharmacokinetics Parameter: Vz/F of INCA036978
Defined as the apparent volume of distribution of INCA036978.
Measured: Up to approximately 2 years
Pharmacokinetics Parameter: t1/2 of INCA036978
Defined as the apparent terminal phase disposition half-life of INCA036978.
Measured: Up to approximately 2 years
For participants with myelofibrosis (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 MF and anemia: Anemia Response as defined in the protocol
For non transfusion-dependent (TD) participants: An Hb increase relative to baseline as defined in the protocol if non-TD at baseline. For TD participants: Achieving transfusion independency (TI) as defined in the protocol.
Measured: Up to approximately 2 years
For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol.
Peripheral blood count remission as defined by the protocol.
Measured: Up to approximately 2 years
For participants with essential thrombocythemia (ET): Peripheral blood count remission as defined by the protocol.
Peripheral blood count remission as defined by the protocol.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start11 May 2026
- Primary completion24 May 2030 (estimated)
- Study completion24 May 2030 (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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441694
- Sponsor's protocol ID
- INCA036978-101
- Other IDs
- 2026-525217-31-00
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT07441694
- Acronym / sponsor ID
- INCA036978-101
- Conditions
- Myeloproliferative Neoplasms
- Keywords
- Myeloproliferative Neoplasms, Myelofibrosis, Essential thrombocythemia, Polycythemia Vera
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 24 May 2030 (estimated)
- Study completion
- 24 May 2030 (estimated)
- First posted
- 2 Mar 2026 (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 will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1a: Dose Escalation | Experimental | Drug: INCA036978INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s). |
| Part 1b: Dose Escalation | Experimental | Drug: INCA036978, Drug: Standard disease-directed therapyINCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s). |
| Part 2a: Dose Expansion | Experimental | Drug: INCA036978INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1 |
| Part 2b: Dose Expansion | Experimental | Drug: INCA036978, Drug: Standard disease-directed therapyINCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Life expectancy > 6 months.
- Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
- Participants with MF, PV and ET as defined in the protocol.
Key exclusion criteria (11 listed)
- Presence of any hematological malignancy other than MF, PV, or ET.
- Malignancy within the last 3 years prior to enrollment.
- Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
- Clinically significant or uncontrolled cardiac disease.
- Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
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 |
|---|---|---|
| INCA036978INCA036978 will be administered at protocol defined dose. | Drug | Part 1a: Dose Escalation, Part 1b: Dose Escalation, Part 2a: Dose Expansion, Part 2b: Dose Expansion |
| Standard disease-directed therapyA standard disease-directed therapy will be administered according to Prescribing Information/SmPC. | Drug | Part 1b: Dose Escalation, Part 2b: Dose Expansion |
Primary outcome
Number of participants with Dose Limiting Toxicities (DLT)s in Part 1
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 approximately 2 years
Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.
Number of participants with TEAEs leading to dose modification or discontinuation
Time frame: Up to approximately 2 years
Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.
13 secondary outcomes
Pharmacokinetics Parameter: Cmax of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Tmax of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Cmax,ss of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Cmin,ss of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: AUC(0-t) of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: AUC 0-∞ of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: CL/F of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Vz/F of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: t1/2 of INCA036978
Time frame: Up to approximately 2 years
For participants with myelofibrosis (MF): Percentage of participants achieving spleen volume reduction as defined in the protocol
Time frame: Week 12 and Week 24
For participants with MF and anemia: Anemia Response as defined in the protocol
Time frame: Up to approximately 2 years
For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol.
Time frame: Up to approximately 2 years
For participants with essential thrombocythemia (ET): Peripheral blood count remission as defined by the protocol.
Time frame: Up to approximately 2 years
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 30 Oct 2026.
- Study of INCA036978 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.
Incyte Medical Monitor study director
Incyte Corporation
54 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCA036978 and Standard disease-directed therapy in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 54 sites in 11 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Australia, Germany, Italy, France and 6 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?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLT)s in Part 1 (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 30 Oct 2026.