A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Recruiting now · Phase 1

Conditions studied: Myeloproliferative Neoplasms

In brief

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

Key facts

Study ID

NCT07008118

Run by

Incyte Corporation

People needed

120

Starts

2025-10-01

Expected to finish

2029-12-14

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Mayo Clinic-Florida — Jacksonville, Florida, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Icahn School of Medicine At Mount Sinai — New York, New York, United States (enrolling)
• University of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• South Austin Medical Center — Austin, Texas, United States (enrolling)
• University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center Blood — Dallas, Texas, United States (enrolling)
• Huntsman Cancer Institute At University of Utah — Salt Lake City, Utah, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Macquarie University Hospital — Sydney, New South Wales, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Universitaire Ziekenhuizen Leuven — Leuven, Belgium
• Universitaetsklinikum Dresden — Dresden, Germany
• Universitatsklinikum Halle (Saale) — Halle, Germany
• Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii — Mainz, Germany
• Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii — Bergamo, Italy
• Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica — Florence, Italy
• Fondazione Irccs Ca Granda Ospedale Maggiore — Milan, Italy

Full record on ClinicalTrials.gov

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