A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Status: Recruiting
Location: See all (47) 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
NOT_YET_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
Hopital Maisonneuve-Rosemont, Montreal, Qc
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
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: 2026-04-27
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