Study of INCA036978 in Participants With Myeloproliferative Neoplasms

NCT07441694 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: INCA036978-1012026-525217-31-00
• Study Type: interventional
• Target: 218
• Locations: 10 countries
• Sites: 49

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.

Conditions

Myeloproliferative Neoplasms

Keywords

Myeloproliferative Neoplasms; Myelofibrosis; Essential thrombocythemia; Polycythemia Vera

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Pharmacokinetics Parameter: Cmax of INCA036978

  Up to approximately 2 years

• Pharmacokinetics Parameter: Tmax of INCA036978

  Up to approximately 2 years

• Pharmacokinetics Parameter: Cmax,ss of INCA036978

  Up to approximately 2 years

• Pharmacokinetics Parameter: Cmin,ss of INCA036978

  Up to approximately 2 years

• Pharmacokinetics Parameter: AUC(0-t) of INCA036978

  Up to approximately 2 years

Study Arms (4)

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).

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).

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

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.

Drug: INCA036978; Drug: Standard disease-directed therapy

Interventions

Standard disease-directed therapy DRUG

A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Part 1b: Dose Escalation; Part 2b: Dose Expansion

INCA036978 DRUG

INCA036978 will be administered at protocol defined dose.

Part 1a: Dose Escalation; Part 1b: Dose Escalation; Part 2a: Dose Expansion; Part 2b: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (49)

University of Alabama At Birmingham

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

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

Yale Cancer Center

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

University of Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

John Hopkins Hospital

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63108, United States

NOT YET RECRUITING

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

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

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Tristar Bmt/Tcto

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Concord General Repatriation Hospital

Concord, New South Wales, 02139, Australia

RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, 02065, Australia

NOT YET RECRUITING

Icon Cancer Centre

Auchenflower, Queensland, 04066, Australia

RECRUITING

Epworth Health Care

East Melbourne, Victoria, 03002, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, 06009, Australia

RECRUITING

Centre Hospitalier Universitaire (Chu) de Liege

Liège, 04000, Belgium

NOT YET RECRUITING

AZ DELTA

Roeselare, 08800, Belgium

NOT YET RECRUITING

McGill University Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

NOT YET RECRUITING

Institut Bergonie

Bordeaux, 33076, France

NOT YET RECRUITING

Hospital Saint Louis

Paris, 75010, France

NOT YET RECRUITING

Institut Gustave Roussy

Villejuif, 94805, 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

National Cancer Center Hospital East

Kashiwa Chiba, 277-0882, Japan

NOT YET RECRUITING

Ehime University Hospital

Toon, Ehime, 791-0204, Japan

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

Related Links

• Study of INCA036978 in Participants With Myeloproliferative Neoplasms

MeSH Terms

Conditions

Myeloproliferative Disorders; Primary Myelofibrosis; Thrombocythemia, Essential; Polycythemia Vera

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 2, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): May 24, 2030
• Study Completion (Estimated): May 24, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); FR (3); ES (3); GB (3); AU (5); DE (4); BE (2); US (22); IT (4); CA (1)