Study of INCA036978 in Participants With Myeloproliferative Neoplasms

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.

Study Overview

• Status: Recruiting
• Conditions: Myeloproliferative Neoplasms
• Intervention / Treatment: Drug: Standard disease-directed therapy; Drug: INCA036978

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Phase 1

Contacts and Locations

• Study Contact: 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

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 02139
      • Recruiting
      • Concord General Repatriation Hospital
    • St Leonards, New South Wales, Australia, 02065
      • Not yet recruiting
      • Royal North Shore Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 04066
      • Recruiting
      • Icon Cancer Centre
  • Victoria
    • East Melbourne, Victoria, Australia, 03002
      • Recruiting
      • Epworth Health Care
  • Western Australia
    • Nedlands, Western Australia, Australia, 06009
      • Recruiting
      • Linear Clinical Research
• Belgium
  • Liège, Belgium, 04000
    • Not yet recruiting
    • Centre Hospitalier Universitaire (Chu) de Liege
  • Roeselare, Belgium, 08800
    • Not yet recruiting
    • AZ Delta
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Not yet recruiting
      • McGill University Jewish General Hospital
• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • Institut Bergonie
  • Paris, France, 75010
    • Not yet recruiting
    • Hospital Saint Louis
  • Villejuif, France, 94805
    • Not yet recruiting
    • Institut Gustave Roussy
• Germany
  • Aachen, Germany, D-52074
    • Not yet recruiting
    • University Medical Center Rwth Aachen
  • Berlin, Germany, 10117
    • Not yet recruiting
    • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Freiburg im Breisgau, Germany, 79106
    • Not yet recruiting
    • Universitatklinikum Freiburg
  • Mainz, Germany, 55131
    • Not yet recruiting
    • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
• Italy
  • Bologna, Italy, 40138
    • Not yet recruiting
    • Aou Policlinico S. Orsola-Malpighi
  • Milan, Italy, 20122
    • Not yet recruiting
    • Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
  • Roma, Italy, 00168
    • Not yet recruiting
    • A. Gemelli University Hospital, Catholic University of the Sacred Heart
  • Udine, Italy, 33100
    • Not yet recruiting
    • Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
• Japan
  • Kashiwa Chiba, Japan, 277-0882
    • Not yet recruiting
    • National Cancer Center Hospital East
  • Toon, Ehime, Japan, 791-0204
    • Not yet recruiting
    • Ehime University Hospital
• Spain
  • Badalona, Spain, 08916
    • Not yet recruiting
    • Hospital Universitari Germans Trias i Pujol
  • Las Palmas de Gran Canaria, Spain, 35010
    • Not yet recruiting
    • Hospital Universitario de Gran Canaria Dr. Negrin
  • Madrid, Spain, 28041
    • Not yet recruiting
    • Hospital Universitario 12 de Octubre
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Not yet recruiting
    • Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
  • Nottingham, United Kingdom, NG5 1PB
    • Not yet recruiting
    • Nottingham University Hospitals
  • Oxford, United Kingdom, OX3 7LE
    • Not yet recruiting
    • University of Oxford
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Not yet recruiting
      • University of Alabama at Birmingham
  • California
    • Irvine, California, United States, 92618
      • Not yet recruiting
      • City of Hope-Lennar Foundation Cancer Center
    • Los Angeles, California, United States, 90033
      • Not yet recruiting
      • Usc Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • UCLA Medical Hematology & Oncology
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Not yet recruiting
      • Yale Cancer Center
  • Florida
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami
    • Tampa, Florida, United States, 33612
      • Not yet recruiting
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Winship Cancer Institute of Emory University
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Not yet recruiting
      • John Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Massachusetts General Hospital
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Not yet recruiting
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Weill Cornell Medicine
    • New York, New York, United States, 10029
      • Not yet recruiting
      • Mount Sinai School of Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Not yet recruiting
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28204
      • Not yet recruiting
      • Levine Cancer Institute
    • Durham, North Carolina, United States, 27705
      • Not yet recruiting
      • Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Not yet recruiting
      • Ohio State University
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Not yet recruiting
      • Tristar Bmt/Tcto
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • University of Texas M. D. Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Not yet recruiting
      • Huntsman Cancer Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1a: Dose Escalation; INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s).	Drug: INCA036978; INCA036978 will be administered at protocol defined dose.
Experimental: Part 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).	Drug: Standard disease-directed therapy; A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.; Drug: INCA036978; INCA036978 will be administered at protocol defined dose.
Experimental: Part 2a: Dose Expansion; INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1	Drug: INCA036978; INCA036978 will be administered at protocol defined dose.
Experimental: Part 2b: Dose Expansion; INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1.	Drug: Standard disease-directed therapy; A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.; Drug: INCA036978; INCA036978 will be administered at protocol defined dose.

What is the study measuring?

Primary 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

Helpful Links

• Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2026
• Primary Completion (Estimated): May 24, 2030
• Study Completion (Estimated): May 24, 2030

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Myeloproliferative Neoplasms; Myelofibrosis; Polycythemia Vera; Essential thrombocythemia
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Blood Coagulation Disorders; Bone Marrow Diseases; Hemorrhagic Disorders; Blood Platelet Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Hemic and Lymphatic Diseases; Thrombocytosis; Myeloproliferative Disorders; Thrombocythemia, Essential; Polycythemia Vera; Primary Myelofibrosis
• Other Study ID Numbers: INCA036978-101; 2026-525217-31-00 (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