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Incyte CorporationStudy of INCA036978 in Participants With Myeloproliferative Neoplasms Phase 1 218
Clinical Trial NCT07441694 is designed to study Treatment for Myeloproliferative Neoplasms. It is a Phase 1 interventional study that is recruiting, having started on 29 March 2026, with plans to enroll 218 participants. Led by Incyte Corporation, it is expected to complete by 24 May 2030. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief 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.
Official Title
A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Conditions
Myeloproliferative NeoplasmsOther Study IDs
- INCA036978-101
NCT ID Number
Start Date (Actual)
2026-03-29
Last Update Posted
2026-03-19
Completion Date (Estimated)
2030-05-24
Enrollment (Estimated)
218
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Myeloproliferative Neoplasms
Myelofibrosis
Essential thrombocythemia
Polycythemia Vera
Myelofibrosis
Essential thrombocythemia
Polycythemia Vera
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart 1a: Dose Escalation INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s). | INCA036978 INCA036978 will be administered at protocol defined dose. |
ExperimentalPart 1b: Dose Escalation 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). | INCA036978 INCA036978 will be administered at protocol defined dose. Standard disease-directed therapy A standard disease-directed therapy will be administered according to Prescribing Information/SmPC. |
ExperimentalPart 2a: Dose Expansion INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1 | INCA036978 INCA036978 will be administered at protocol defined dose. |
ExperimentalPart 2b: Dose Expansion INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. | INCA036978 INCA036978 will be administered at protocol defined dose. Standard disease-directed therapy A standard disease-directed therapy will be administered according to Prescribing Information/SmPC. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | Up to approximately 2 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pharmacokinetics Parameter: Cmax of INCA036978 | Defined as maximum observed plasma concentration of INCA036978. | Up to approximately 2 years |
Pharmacokinetics Parameter: Tmax of INCA036978 | Defined as the time to reach the maximum plasma concentration of INCA036978. | Up to approximately 2 years |
Pharmacokinetics Parameter: Cmax,ss of INCA036978 | Defined as the maximum observed plasma concentration at steady state of INCA036978. | Up to approximately 2 years |
Pharmacokinetics Parameter: Cmin,ss of INCA036978 | Defined as the minimum observed plasma concentration at steady state of INCA036978. | 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. | 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. | Up to approximately 2 years |
Pharmacokinetics Parameter: CL/F of INCA036978 | Defined as the apparent clearance of INCA036978. | Up to approximately 2 years |
Pharmacokinetics Parameter: Vz/F of INCA036978 | Defined as the apparent volume of distribution of INCA036978. | Up to approximately 2 years |
Pharmacokinetics Parameter: t1/2 of INCA036978 | Defined as the apparent terminal phase disposition half-life of INCA036978. | 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. | 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. | 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. | 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. | Up to approximately 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
- 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.
Incyte Corporation149 active studies to exploreStudy Central Contact
Contact: Incyte Corporation Call Center (US), 1.855.463.3463, [email protected]
Contact: Incyte Corporation Call Center (ex-US), +800 00027423, [email protected]
45 Study Locations in 8 Countries
New South Wales
Concord General Repatriation Hospital, Concord, New South Wales, 02139, Australia
Not yet recruiting
Royal North Shore Hospital, St Leonards, New South Wales, 02065, Australia
Not yet recruiting
Queensland
Icon Cancer Centre, Auchenflower, Queensland, 04066, Australia
Recruiting
Victoria
Epworth Health Care, East Melbourne, Victoria, 03002, Australia
Recruiting
Western Australia
Linear Clinical Research, Nedlands, Western Australia, 06009, Australia
Not yet recruiting
Alabama
University of Alabama At Birmingham, Birmingham, Alabama, 35233, United States
Not yet recruiting
California
City of Hope-Lennar Foundation Cancer Center, Irvine, California, 92618, United States
Not yet recruiting
Usc Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States
Not yet recruiting
UCLA Medical Hematology & Oncology, Los Angeles, California, 90095, United States
Not yet recruiting
Connecticut
Yale Cancer Center, New Haven, Connecticut, 06510, United States
Not yet recruiting
Florida
University of Miami, Miami, Florida, 33136, United States
Not yet recruiting
Moffitt Cancer Center, Tampa, Florida, 33612, United States
Not yet recruiting
Georgia
Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States
Not yet recruiting
Maryland
John Hopkins Hospital, Baltimore, Maryland, 21287, United States
Not yet recruiting
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Not yet recruiting
Missouri
Washington University School of Medicine, St Louis, Missouri, 63108, United States
Not yet recruiting
New York
Mount Sinai School of Medicine, New York, New York, 10029, United States
Not yet recruiting
Weill Cornell Medicine, New York, New York, 10065, United States
Not yet recruiting
North Carolina
University of North Carolina At Chapel Hill, Chapel Hill, North Carolina, 27514, United States
Not yet recruiting
Levine Cancer Institute, Charlotte, North Carolina, 28204, United States
Not yet recruiting
Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy, Durham, North Carolina, 27705, United States
Not yet recruiting
Ohio
Cleveland Clinic, Cleveland, Ohio, 44195, United States
Not yet recruiting
Ohio State University, Columbus, Ohio, 43210, United States
Not yet recruiting
Tennessee
Tristar Bmt/Tcto, Nashville, Tennessee, 37203, United States
Not yet recruiting
Texas
University of Texas M. D. Anderson Cancer Center, Houston, Texas, 77030, United States
Not yet recruiting
Utah
Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States
Not yet recruiting
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Not yet recruiting
Centre Hospitalier Universitaire (Chu) de Liege, Liège, 04000, Belgium
Not yet recruiting
AZ DELTA, Roeselare, 08800, Belgium
Not yet recruiting
Institut Bergonie, Bordeaux, 33076, France
Not yet recruiting
Hospital Saint Louis, Paris, 75010, France
Not yet recruiting
University Medical Center Rwth Aachen, Aachen, D-52074, Germany
Not yet recruiting
Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin, 10117, Germany
Not yet recruiting
Universitatklinikum Freiburg, Freiburg im Breisgau, 79106, Germany
Not yet recruiting
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz, 55131, Germany
Not yet recruiting
Aou Policlinico S. Orsola-Malpighi, Bologna, 40138, Italy
Not yet recruiting
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico, Milan, 20122, Italy
Not yet recruiting
A. Gemelli University Hospital, Catholic University of the Sacred Heart, Roma, 00168, Italy
Not yet recruiting
Azienda Sanitaria Universitaria Friuli Centrale Asu Fc, Udine, 33100, Italy
Not yet recruiting
Hospital Universitari Germans Trias I Pujol, Badalona, 08916, Spain
Not yet recruiting
Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, 35010, Spain
Not yet recruiting
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Not yet recruiting
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust, London, SE1 9RT, United Kingdom
Not yet recruiting
Nottingham University Hospitals, Nottingham, NG5 1PB, United Kingdom
Not yet recruiting
University of Oxford, Oxford, OX3 7LE, United Kingdom
Not yet recruiting