A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

NCT07008118 | Recruiting Phase 1 FDA Drug

• 1 other identifier: INCA035784-101
• Study Type: interventional
• Target: 120
• Locations: 5 countries
• Sites: 23

Brief Summary

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

Conditions

Myeloproliferative Neoplasms

Keywords

Myeloproliferative Neoplasms; Myelofibrosis; Essential thrombocythemia; CALR mutation

Outcome Measures

Primary Outcomes (3)

• Number of participants with Dose Limiting Toxicities (DLTs)

  Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

  Up to 28 days

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug.

  Up to approximately 2 years and 90 days

• Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay

  Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay.

  Up to approximately 2 years and 90 days

Secondary Outcomes (16)

• Number of participants with TEAEs leading to dose modification or discontinuation

  Up to approximately 2 years and 90 days

• Participants with MF: Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria for myelofibrosis (MF)

  Up to approximately 2 years and 90 days

• Participants with essential thrombocythemia (ET): Response using the revised IWG-MRT and ELN response criteria for ET

  Up to approximately 2 years and 90 days

• Participants with symptomatic anemia: Anemia response

  Up to approximately 2 years and 90 days

• Participants with spleen volume (SV) ≥ 450 mL at baseline: Percentage of participants achieving spleen volume reduction of ≥ 35% (SVR35)

  Week 12 and Week 24

Study Arms (2)

Part 1a: Dose escalation

EXPERIMENTAL

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.

Drug: INCA035784

Part 1b: Dose expansion

EXPERIMENTAL

INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group.

Drug: INCA035784

Interventions

INCA035784 DRUG

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

Part 1a: Dose escalation; Part 1b: Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (23)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Mayo Clinic-Florida

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Icahn School of Medicine At Mount Sinai

New York, New York, 10029, United States

RECRUITING

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

South Austin Medical Center

Austin, Texas, 78704, United States

RECRUITING

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

Dallas, Texas, 75235, United States

NOT YET RECRUITING

Huntsman Cancer Institute At University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Macquarie University Hospital

Sydney, New South Wales, 02109, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 05000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 03004, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, 06009, Australia

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 01200, Belgium

NOT YET RECRUITING

Universitaire Ziekenhuizen Leuven

Leuven, 03000, Belgium

NOT YET RECRUITING

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

NOT YET RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

Bergamo, 24127, Italy

NOT YET RECRUITING

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

Florence, 50134, Italy

NOT YET RECRUITING

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122, Italy

NOT YET RECRUITING

Centro Ricerche Cliniche Di Verona

Verona, 37134, Italy

NOT YET RECRUITING

Related Links

• A study to evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

MeSH Terms

Conditions

Myeloproliferative Disorders; Primary Myelofibrosis; Thrombocythemia, Essential

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): December 14, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); AU (4); IT (4); BE (2); DE (1)