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Myeloproliferative NeoplasmsPhase 1NCT07008118

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

A Phase 1 study testing INCA035784 in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 26 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloproliferative Neoplasms
What is being tested?
INCA035784
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
26 sitesin 5 countries
Study dates
1 Oct 2025to 14 Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

26 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

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

26 sites in 5 countries

United States12 sites, 12 recruiting

  • South Austin Medical Center

    Austin, Texas, 78704

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Recruiting

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27514

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

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

    Dallas, Texas, 75235

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Recruiting

  • Mayo Clinic-Florida

    Jacksonville, Florida, 32224

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

    Recruiting

  • Huntsman Cancer Institute At University of Utah

    Salt Lake City, Utah, 84112

    Recruiting

Other trials in United States

Australia4 sites, 4 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 05000

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 03004

    Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, 06009

    Recruiting

  • Macquarie University Hospital

    Sydney, New South Wales, 02109

    Recruiting

Other trials in Australia

Italy4 sites, 4 recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

    Bergamo, 24127

    Not yet recruiting

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

    Florence, 50134

    Not yet recruiting

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122

    Not yet recruiting

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134

    Not yet recruiting

Other trials in Italy

Belgium3 sites, 3 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 01200

    Not yet recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 09000

    Not yet recruiting

  • Universitaire Ziekenhuizen Leuven

    Leuven, 03000

    Not yet recruiting

Other trials in Belgium

Germany3 sites, 3 recruiting

  • Universitaetsklinikum Dresden

    Dresden, 01307

    Not yet recruiting

  • Universitatsklinikum Halle (Saale)

    Halle, 06120

    Not yet recruiting

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131

    Not yet recruiting

Other trials in Germany

About this study

Official title: A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms

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

Being tested
INCA035784
Keywords
Myeloproliferative Neoplasms, Myelofibrosis, Essential thrombocythemia, CALR mutation
Medical subject headings
Myeloproliferative Disorders, Primary Myelofibrosis, Thrombocythemia, Essential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCA035784Drug

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

Study groups in NCT07008118
Study groupRoleWhat they receive
Part 1a: Dose escalationExperimentalINCA035784 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.
Receives: Drug: INCA035784
Part 1b: Dose expansionExperimentalINCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group.
Receives: Drug: INCA035784

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 28 days

  2. 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.

    Measured: Up to approximately 2 years and 90 days

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

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

    Measured: Up to approximately 2 years and 90 days

Secondary outcomes (16)

  1. Number of participants with TEAEs leading to dose modification or discontinuation

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

    Measured: Up to approximately 2 years and 90 days

  2. 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)

    Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.

    Measured: Up to approximately 2 years and 90 days

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

    Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.

    Measured: Up to approximately 2 years and 90 days

  4. Participants with symptomatic anemia: Anemia response

    Anemia response as defined in the protocol.

    Measured: Up to approximately 2 years and 90 days

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

    Defined as percentage of participants with a protocol defined Spleen Volume Reduction of ≥ 35% (SVR35).

    Measured: Week 12 and Week 24

  6. Participants with SV ≥ 450 mL at baseline: Percentage of participants achieving spleen volume reduction of ≥ 25% (SVR25)

    Defined as percentage of participants with a protocol defined Spleen Volume Reduction of ≥ 25% (SVR25).

    Measured: Week 12 and Week 24

  7. Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS)

    Defined as the percentage of participants achieving ≥ 50% reduction from baseline of TSS.

    Measured: Week 12 and Week 24

  8. Mean change from baseline in TSS

    Mean change of TSS from baseline.

    Measured: Week 12 and Week 24

  9. Pharmacokinetics Parameter (PK): Cmax of INCA035784

    Defined as maximum observed plasma concentration of INCA035784.

    Measured: Up to approximately 2 years and 90 days

  10. Pharmacokinetics Parameter: Tmax of INCA035784

    Defined as the time to reach the maximum plasma concentration of INCA035784.

    Measured: Up to approximately 2 years and 90 days

  11. Pharmacokinetics Parameter: Cmin of INCA035784

    Defined as the minimum observed plasma concentration of INCA035784.

    Measured: Up to approximately 2 years and 90 days

  12. Pharmacokinetics Parameter: AUC(0-t) of INCA035784

    Defined as the area under the concentration-time curve up to the last measurable concentration of INCA035784.

    Measured: Up to approximately 2 years and 90 days

  13. Pharmacokinetics Parameter: AUC 0-∞ of INCA035784

    Defined as the area under the concentration-time curve from 0 to infinity of INCA035784.

    Measured: Up to approximately 2 years and 90 days

  14. Pharmacokinetics Parameter: CL of INCA035784

    Defined as the apparent oral dose clearance of INCA035784.

    Measured: Up to approximately 2 years and 90 days

  15. Pharmacokinetics Parameter: Vz of INCA035784

    Defined as the apparent oral dose volume of distribution of INCA035784.

    Measured: Up to approximately 2 years and 90 days

  16. Pharmacokinetics Parameter: t1/2 of INCA035784

    Defined as the apparent terminal phase disposition half-life of INCA035784.

    Measured: Up to approximately 2 years and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2025
  2. Study start1 Oct 2025
  3. Primary completion14 Mar 2028 (estimated)
  4. Study completion14 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07008118
Sponsor's protocol ID
INCA035784-101
Status last verified
Aug 2026
First submitted
29 May 2025
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCA035784 in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 26 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Australia, Italy, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07008118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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