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NCT07008118PHASE1Recruiting

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Incyte Corporation

Start Date

10/1/2025

Completion Date

12/14/2029

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

INCA035784

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Conditions

Myeloproliferative Neoplasms

Locations

Mayo Clinic Hospital

Phoenix, Arizona 85054

United States

Stanford University

Palo Alto, California 94304

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Mayo Clinic-Florida

Jacksonville, Florida 32224

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Icahn School of Medicine At Mount Sinai

New York, New York 10029

United States

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina 27514

United States

South Austin Medical Center

Austin, Texas 78704

United States

University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center Blood

Dallas, Texas 75235

United States

Huntsman Cancer Institute At University of Utah

Salt Lake City, Utah 84112

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Macquarie University Hospital

Sydney, New South Wales 02109

Australia

Royal Adelaide Hospital

Adelaide, South Australia 05000

Australia

The Alfred Hospital

Melbourne, Victoria 03004

Australia

Linear Clinical Research

Nedlands, Western Australia 06009

Australia

Cliniques Universitaires Saint-Luc

Brussels, 01200

Belgium

Universitair Ziekenhuis Gent

Ghent, 09000

Belgium

Universitaire Ziekenhuizen Leuven

Leuven, 03000

Belgium

Universitaetsklinikum Dresden

Dresden, 01307

Germany

Universitatsklinikum Halle (Saale)

Halle, 06120

Germany

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131

Germany

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

Bergamo, 24127

Italy

Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica

Florence, 50134

Italy

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122

Italy

Centro Ricerche Cliniche Di Verona

Verona, 37134

Italy