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NCT07441694PHASE1Recruiting

Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Incyte Corporation

Start Date

5/11/2026

Completion Date

5/24/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

INCA036978

DRUG

Standard disease-directed therapy

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Conditions

Myeloproliferative Neoplasms

Locations

University of Alabama At Birmingham

Birmingham, Alabama 35233

United States

City of Hope-Lennar Foundation Cancer Center

Irvine, California 92618

United States

Usc Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

UCLA Medical Hematology & Oncology

Los Angeles, California 90095

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

University of Miami

Miami, Florida 33136

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

United States

John Hopkins Hospital

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Washington University School of Medicine

St Louis, Missouri 63108

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

Mount Sinai School of Medicine

New York, New York 10029

United States

Weill Cornell Medicine

New York, New York 10065

United States

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina 27514

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy

Durham, North Carolina 27705

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Ohio State University

Columbus, Ohio 43210

United States

Tristar Bmt/Tcto

Nashville, Tennessee 37203

United States

University of Texas M. D. Anderson Cancer Center

Houston, Texas 77030

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Concord General Repatriation Hospital

Concord, New South Wales 02139

Australia

Royal North Shore Hospital

St Leonards, New South Wales 02065

Australia

Icon Cancer Centre

Auchenflower, Queensland 04066

Australia

Epworth Health Care

East Melbourne, Victoria 03002

Australia

Linear Clinical Research

Nedlands, Western Australia 06009

Australia

Centre Hospitalier Universitaire (Chu) de Liege

Liège, 04000

Belgium

AZ DELTA

Roeselare, 08800

Belgium

Princess Margaret Cancer Center

Toronto, Ontario M5G 2M9

Canada

McGill University Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Institut Bergonie

Bordeaux, 33076

France

Hospital Saint Louis

Paris, 75010

France

Institut Gustave Roussy

Villejuif, 94805

France

University Medical Center Rwth Aachen

Aachen, D-52074

Germany

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117

Germany

Universitatklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Universitatsklinikum Halle (Saale)

Halle, 06120

Germany

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131

Germany

Aou Policlinico S. Orsola-Malpighi

Bologna, 40138

Italy

Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122

Italy

A. Gemelli University Hospital, Catholic University of the Sacred Heart

Roma, 00168

Italy

Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

Udine, 33100

Italy

National Cancer Center Hospital East

Kashiwa Chiba, 277-0882

Japan

Ehime University Hospital

Toon, Ehime, 791-0204

Japan

Seoul National University Hospital

Jongno-gu, Seoul, 03080

South Korea

The Catholic University of Korea Seoul St. Mary'S Hospital

Seocho-gu, Seoul, 06591

South Korea

Hospital Universitari Germans Trias I Pujol

Badalona, 08916

Spain

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35010

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

London, SE1 9RT

United Kingdom

Nottingham University Hospitals

Nottingham, NG5 1PB

United Kingdom

University of Oxford

Oxford, OX3 7LE

United Kingdom