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Clinical Trials in Spain / NCT07441694
Recruiting Phase 1

Study of INCA036978 in Participants With Myeloproliferative Neoplasms

NCT07441694 · tracked via the Priya Life Science Spain tracker
Sponsor
Incyte Corporation
Phase
Phase 1
Started
2026-05-11
Last updated
2026-10-09

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
No
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)

FacilityCityRegionStatus
University of Alabama At Birmingham Birmingham Alabama Not Yet Recruiting
City of Hope-Lennar Foundation Cancer Center Irvine California 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 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 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 Recruiting
McGill University Jewish General Hospital Montreal Quebec Not Yet Recruiting
Francois-Xavier Bordeaux France Not Yet Recruiting
Hospital Saint Louis Paris France Recruiting
Institut Gustave Roussy Villejuif France Recruiting
University Medical Center Rwth Aachen Aachen Germany Recruiting
Charite Universitaetsmedizin Berlin - Campus Charite Mitte Berlin Germany Not Yet Recruiting
Universitatklinikum Freiburg Freiburg im Breisgau Germany 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 Spain

A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia Recruiting
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) Active, not recruiting
Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2) 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
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms 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
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 Spain