A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
Purpose
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
Condition
- Myeloproliferative Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1a: Dose escalation |
INCA035784 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myeloproliferative neoplasm (MPN) will enroll in this group. |
|
|
Experimental Part 1b: Dose expansion |
INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group. |
|
Recruiting Locations
Stanford University
Palo Alto, California 94304
Palo Alto, California 94304
Colorado Blood Cancer Institute
Denver, Colorado 80218
Denver, Colorado 80218
Icahn School of Medicine At Mount Sinai
New York, New York 10029
New York, New York 10029
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
South Austin Medical Center
Austin, Texas 78704
Austin, Texas 78704
Huntsman Cancer Institute At University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation