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Recruiting Phase 1 NCT07441694

Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Phase 1 – testing safety in a small group of people
Conditions: Myeloproliferative Neoplasms

Sponsor: Incyte Corporation

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 9
Australia (1)
Concord General Repatriation Hospital
Concord , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Centre Hospitalier Universitaire (Chu) de Liege
Liège
NOT_YET_RECRUITING
Canada (1)
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal , Quebec
NOT_YET_RECRUITING
France (1)
Institut Bergonie
Bordeaux
NOT_YET_RECRUITING
Germany (1)
University Medical Center Rwth Aachen
Aachen
NOT_YET_RECRUITING
Italy (1)
Aou Policlinico S. Orsola-Malpighi
Bologna
NOT_YET_RECRUITING
Spain (1)
Hospital Universitari Germans Trias I Pujol
Badalona
NOT_YET_RECRUITING
United Kingdom (1)
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London
NOT_YET_RECRUITING
United States (1)
University of Alabama At Birmingham
Birmingham , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
27.04.2026
Completion date
24.05.2030
Registry ID
NCT07441694
Source
anzctr
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