Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Recruiting now · Phase 1

Conditions studied: Myeloproliferative Neoplasms

In brief

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.

Key facts

Study ID

NCT07441694

Run by

Incyte Corporation

People needed

218

Starts

2026-05-11

Expected to finish

2030-05-24

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where it is running

• Tristar Bmt/Tcto — Nashville, Tennessee, United States (enrolling)
• Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
• Epworth Health Care — East Melbourne, Victoria, Australia (enrolling)
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Royal North Shore Hospital — St Leonards, New South Wales, Australia (enrolling)
• Concord General Repatriation Hospital — Concord, New South Wales, Australia (enrolling)
• Icon Cancer Centre — Auchenflower, Queensland, Australia (enrolling)
• Hospital Universitario 12 de Octubre — Madrid, Spain
• City of Hope-Lennar Foundation Cancer Center — Irvine, California, United States
• Hospital Universitario de Gran Canaria Dr. Negrin — Las Palmas de Gran Canaria, Spain
• Usc Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCLA Medical Hematology & Oncology — Los Angeles, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Seoul National University Hospital — Jongno-gu, Seoul, South Korea
• University of Alabama At Birmingham — Birmingham, Alabama, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Oxford — Oxford, United Kingdom
• Hospital Universitari Germans Trias I Pujol — Badalona, Spain
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• University of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States
• John Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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