Study of INCA036978 in Participants With Myeloproliferative Neoplasms

NCT07441694 · tracked via the Priya Life Science UK tracker

Sponsor

Incyte Corporation

Phase

Phase 1

Started

2026-05-11

Last updated

2026-07-22

Condition(s) studied

Myeloproliferative Neoplasms

Investigational drug(s) / intervention(s)

INCA036978Standard disease-directed therapy

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of participants with Dose Limiting Toxicities (DLT)s in Part 1 — Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Number of participants with Treatment-emergent Adverse Events (TEAEs) — Up to approximately 2 years
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.
Number of participants with TEAEs leading to dose modification or discontinuation — Up to approximately 2 years
Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.

Trial sites (54)

Facility	City	Region	Status
University of Alabama At Birmingham	Birmingham	Alabama	Not Yet Recruiting
City of Hope-Lennar Foundation Cancer Center	Irvine	California	Not Yet Recruiting
Usc Norris Comprehensive Cancer Center	Los Angeles	California	Not Yet Recruiting
UCLA Medical Hematology & Oncology	Los Angeles	California	Not Yet Recruiting
Yale Cancer Center	New Haven	Connecticut	Not Yet Recruiting
University of Miami	Miami	Florida	Not Yet Recruiting
Moffitt Cancer Center	Tampa	Florida	Not Yet Recruiting
Winship Cancer Institute of Emory University	Atlanta	Georgia	Recruiting
John Hopkins Hospital	Baltimore	Maryland	Not Yet Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Not Yet Recruiting
Washington University School of Medicine	St Louis	Missouri	Not Yet Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Not Yet Recruiting
Mount Sinai School of Medicine	New York	New York	Not Yet Recruiting
Weill Cornell Medicine	New York	New York	Not Yet Recruiting
University of North Carolina At Chapel Hill	Chapel Hill	North Carolina	Not Yet Recruiting
Levine Cancer Institute	Charlotte	North Carolina	Not Yet Recruiting
Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy	Durham	North Carolina	Not Yet Recruiting
Cleveland Clinic	Cleveland	Ohio	Not Yet Recruiting
Ohio State University	Columbus	Ohio	Recruiting
Tristar Bmt/Tcto	Nashville	Tennessee	Recruiting
University of Texas M. D. Anderson Cancer Center	Houston	Texas	Not Yet Recruiting
Huntsman Cancer Institute	Salt Lake City	Utah	Not Yet Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	Not Yet Recruiting
Concord General Repatriation Hospital	Concord	New South Wales	Recruiting
Royal North Shore Hospital	St Leonards	New South Wales	Recruiting
Icon Cancer Centre	Auchenflower	Queensland	Recruiting
Epworth Health Care	East Melbourne	Victoria	Recruiting
Linear Clinical Research	Nedlands	Western Australia	Recruiting
Centre Hospitalier Universitaire (Chu) de Liege	Liège	Belgium	Not Yet Recruiting
AZ DELTA	Roeselare	Belgium	Not Yet Recruiting
Princess Margaret Cancer Center	Toronto	Ontario	Not Yet Recruiting
McGill University Jewish General Hospital	Montreal	Quebec	Not Yet Recruiting
Institut Bergonie	Bordeaux	France	Not Yet Recruiting
Hospital Saint Louis	Paris	France	Not Yet Recruiting
Institut Gustave Roussy	Villejuif	France	Not Yet Recruiting
University Medical Center Rwth Aachen	Aachen	Germany	Not Yet Recruiting
Charite Universitaetsmedizin Berlin - Campus Charite Mitte	Berlin	Germany	Not Yet Recruiting
Universitatklinikum Freiburg	Freiburg im Breisgau	Germany	Not Yet Recruiting
Universitatsklinikum Halle (Saale)	Halle	Germany	Not Yet Recruiting
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii	Mainz	Germany	Not Yet Recruiting

+ 14 more sites — see the full list on the official registry below.

More Incyte Corporation trials in the UK

Study of INCB123667 in Subjects With Advanced Solid Tumors Active, not recruiting

A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors Recruiting

Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders Recruiting

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients Active, not recruiting

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease Active, not recruiting

Other trials for the same condition

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms Active, not recruiting

A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441694 on ClinicalTrials.gov ↗ ← All trials in the UK