Recruiting
Phase 1

INCA035784

Sponsor:

Incyte Corporation

Code:

NCT07008118

Conditions

Myeloproliferative Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCA035784

Study Details

Brief summary:

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

Conditions

Myeloproliferative Neoplasms

Study ID

NCT07008118

Start date

Oct 1, 2025

Status verified date

Aug, 2026

Completion date

Dec 14, 2029

Anticipated

Primary completion date

Mar 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years and 90 days ]
  • Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay [ Time Frame: Up to approximately 2 years and 90 days ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Mayo Clinic Hospital

Recruiting

Phoenix, Arizona, United States, 85054

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Mayo Clinic-Florida

Recruiting

Jacksonville, Florida, United States, 32224

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Icahn School of Medicine At Mount Sinai

Recruiting

New York, New York, United States, 10029

University of North Carolina At Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

South Austin Medical Center

Recruiting

Austin, Texas, United States, 78704

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

Recruiting

Dallas, Texas, United States, 75235

Huntsman Cancer Institute At University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Incyte Corporation

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Myeloproliferative Neoplasms
  • Myelofibrosis
  • Essential thrombocythemia
  • CALR mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-08-06.