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Clinical Trials in the USA / NCT07008118
Recruiting Phase 1

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

NCT07008118 · tracked via the Priya Life Science USA tracker
Sponsor
Incyte Corporation
Phase
Phase 1
Started
2025-10-01
Last updated
2026-08-06

Condition(s) studied

Myeloproliferative Neoplasms

Investigational drug(s) / intervention(s)

INCA035784

INCA035784: INCA035784 will be administered at the assigned dose in the dose escalation part and at the protocol defined dose in the dose expansion part.

Study summary

This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older at the time of signing the ICF * ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b) * Documented CALR exon-9 mutation * Confirmed diagnosis of MPN according to the 2022 ICC criteria: * DIPSS+ intermediate-2/high-risk MF with prior JAKi, \<20% blasts, and measurable spleen * High-risk ET with platelets \>450×10⁹/L * Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET (unless only a single standard-of-care option is approved in the participating country) * No prior stem cell transplant and none planned within 6 months * Minimum Laboratory Requirements: * Platelet count ≥50 × 10⁹/L * Absolute neutrophil count ≥1 × 10⁹/L * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 × ULN * Total bilirubin \<2 × ULN * Estimated creatinine clearance \>45 or \>30 mL/min (depending on study part) Exclusion Criteria: * Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months * Active or high-risk HBV, HCV, 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 (e.g., 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 Inclusion/Exclusion Criteria may apply.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona Recruiting
Stanford University Palo Alto California Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
Mayo Clinic-Florida Jacksonville Florida Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Johns Hopkins University Baltimore Maryland Recruiting
Icahn School of Medicine At Mount Sinai New York New York Recruiting
University of North Carolina At Chapel Hill Chapel Hill North Carolina Recruiting
South Austin Medical Center Austin Texas Recruiting
University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center Blood Dallas Texas Recruiting
Huntsman Cancer Institute At University of Utah Salt Lake City Utah Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Macquarie University Hospital Sydney New South Wales Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Linear Clinical Research Nedlands Western Australia Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Not Yet Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Not Yet Recruiting
Universitaire Ziekenhuizen Leuven Leuven Belgium Not Yet Recruiting
Universitaetsklinikum Dresden Dresden Germany Not Yet Recruiting
Universitatsklinikum Halle (Saale) Halle Germany Not Yet Recruiting
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Mainz Germany Not Yet Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii Bergamo Italy Not Yet Recruiting
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica Florence Italy Not Yet Recruiting
Fondazione Irccs Ca Granda Ospedale Maggiore Milan Italy Not Yet Recruiting
Centro Ricerche Cliniche Di Verona Verona Italy Not Yet Recruiting

More Incyte Corporation trials in the USA

Other trials for the same condition

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 NCT07008118 on ClinicalTrials.gov ↗ ← All trials in the USA