Actively Recruiting
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
Led by Incyte Corporation · Updated on 2026-04-06
120
Participants Needed
26
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
CONDITIONS
Official Title
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing the informed consent form
- ECOG performance status of 0 to 1 for dose escalation and 0 to 2 for dose expansion
- Documented CALR exon-9 mutation
- Confirmed diagnosis of myeloproliferative neoplasms per 2022 ICC criteria
- DIPSS+ intermediate-2 or high-risk myelofibrosis with prior JAK inhibitor, less than 20% blasts, and measurable spleen
- High-risk essential thrombocythemia with platelets over 450 x 10^9/L
- Resistant, refractory, intolerant, or lost response to at least 1 prior therapy for myelofibrosis and at least 2 prior therapies for essential thrombocythemia (unless only one standard option is approved locally)
- No prior stem cell transplant and none planned within 6 months
- Laboratory requirements including platelet count at least 50 x 10^9/L, absolute neutrophil count at least 1 x 10^9/L, INR and aPTT less than or equal to 1.5 times upper limit of normal (unless on vitamin K antagonists), ALT and AST less than 2.5 times upper limit of normal, total bilirubin less than 2 times upper limit of normal, and creatinine clearance over 45 or 30 mL/min depending on study part
You will not qualify if you...
- Major bleeding or thrombosis such as stroke, deep vein thrombosis, or pulmonary embolism within the past 3 months
- Active or high-risk hepatitis B, hepatitis C, or HIV infection, or other chronic active infections requiring systemic treatment
- Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers like resected skin, cervical, thyroid, or prostate cancer
- Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
4
Mayo Clinic-Florida
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
5
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
6
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
7
Icahn School of Medicine At Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
8
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
9
South Austin Medical Center
Austin, Texas, United States, 78704
Actively Recruiting
10
University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center Blood
Dallas, Texas, United States, 75235
Not Yet Recruiting
11
Huntsman Cancer Institute At University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
12
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
13
Macquarie University Hospital
Sydney, New South Wales, Australia, 02109
Actively Recruiting
14
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 05000
Actively Recruiting
15
The Alfred Hospital
Melbourne, Victoria, Australia, 03004
Actively Recruiting
16
Linear Clinical Research
Nedlands, Western Australia, Australia, 06009
Actively Recruiting
17
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 01200
Not Yet Recruiting
18
Universitair Ziekenhuis Gent
Ghent, Belgium, 09000
Not Yet Recruiting
19
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 03000
Not Yet Recruiting
20
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Not Yet Recruiting
21
Universitatsklinikum Halle (Saale)
Halle, Germany, 06120
Not Yet Recruiting
22
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, Germany, 55131
Not Yet Recruiting
23
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Bergamo, Italy, 24127
Not Yet Recruiting
24
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
Florence, Italy, 50134
Not Yet Recruiting
25
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, Italy, 20122
Not Yet Recruiting
26
Centro Ricerche Cliniche Di Verona
Verona, Italy, 37134
Not Yet Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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