A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama At Birmingham
NOT_YET_RECRUITING
Birmingham
California
City of Hope-Lennar Foundation Cancer Center
NOT_YET_RECRUITING
Irvine
UCLA Medical Hematology & Oncology
NOT_YET_RECRUITING
Los Angeles
Usc Norris Comprehensive Cancer Center
NOT_YET_RECRUITING
Los Angeles
Connecticut
Yale Cancer Center
NOT_YET_RECRUITING
New Haven
Florida
University of Miami
NOT_YET_RECRUITING
Miami
Moffitt Cancer Center
NOT_YET_RECRUITING
Tampa
Georgia
Winship Cancer Institute of Emory University
NOT_YET_RECRUITING
Atlanta
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Maryland
John Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Missouri
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
North Carolina
University of North Carolina At Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Levine Cancer Institute
NOT_YET_RECRUITING
Charlotte
Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy
NOT_YET_RECRUITING
Durham
New York
Mount Sinai School of Medicine
NOT_YET_RECRUITING
New York
Weill Cornell Medicine
NOT_YET_RECRUITING
New York
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Ohio State University
NOT_YET_RECRUITING
Columbus
Tennessee
Tristar Bmt/Tcto
NOT_YET_RECRUITING
Nashville
Texas
University of Texas M. D. Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Utah
Huntsman Cancer Institute
NOT_YET_RECRUITING
Salt Lake City
Wisconsin
Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Other Locations
Australia
Icon Cancer Centre
RECRUITING
Auchenflower
Concord General Repatriation Hospital
RECRUITING
Concord
Epworth Health Care
RECRUITING
East Melbourne
Linear Clinical Research
RECRUITING
Nedlands
Royal North Shore Hospital
NOT_YET_RECRUITING
St Leonards
Belgium
Centre Hospitalier Universitaire (Chu) de Liege
NOT_YET_RECRUITING
Liège
AZ DELTA
NOT_YET_RECRUITING
Roeselare
Canada
McGill University Jewish General Hospital
NOT_YET_RECRUITING
Montreal
France
Institut Bergonie
NOT_YET_RECRUITING
Bordeaux
Hospital Saint Louis
NOT_YET_RECRUITING
Paris
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
University Medical Center Rwth Aachen
NOT_YET_RECRUITING
Aachen
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
NOT_YET_RECRUITING
Berlin
Universitatklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
NOT_YET_RECRUITING
Mainz
Italy
Aou Policlinico S. Orsola-Malpighi
NOT_YET_RECRUITING
Bologna
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
A. Gemelli University Hospital, Catholic University of the Sacred Heart
NOT_YET_RECRUITING
Roma
Azienda Sanitaria Universitaria Friuli Centrale Asu Fc
NOT_YET_RECRUITING
Udine
Japan
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwa Chiba
Ehime University Hospital
NOT_YET_RECRUITING
Toon, Ehime
Spain
Hospital Universitari Germans Trias I Pujol
NOT_YET_RECRUITING
Badalona
Hospital Universitario de Gran Canaria Dr. Negrin
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
United Kingdom
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
NOT_YET_RECRUITING
London
Nottingham University Hospitals
NOT_YET_RECRUITING
Nottingham
University of Oxford
NOT_YET_RECRUITING
Oxford
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2026-05-11
Estimated Completion Date: 2030-05-24
Participants
Target number of participants: 218
Treatments
Experimental: Part 1a: Dose Escalation
INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s).
Experimental: Part 1b: Dose Escalation
INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s).
Experimental: Part 2a: Dose Expansion
INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1
Experimental: Part 2b: Dose Expansion
INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation