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NCT Number: NCT07441694

Study of INCA036978 in Participants With Myeloproliferative Neoplasms

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.

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Key information

Conditions

Myeloproliferative Neoplasms Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Bone Marrow Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Neoplasms Neoplasms by Site Polycythemia Vera Primary Myelofibrosis Thrombocythemia, Essential Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Concord General Repatriation Hospital, Concord, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Life expectancy > 6 months.
  • Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
  • Participants with MF, PV and ET as defined in the protocol.

Exclusion criteria

  • Presence of any hematological malignancy other than MF, PV, or ET.
  • Malignancy within the last 3 years prior to enrollment.
  • Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
  • Clinically significant or uncontrolled cardiac disease.
  • Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
  • Laboratory values outside the Protocol-defined ranges.
  • Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.
  • Presence of chronic or current active infectious disease requiring systemic treatment.
  • Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.
  • Prior radiation therapy within 28 days before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Treatment and study plan

INCA036978

Drug

INCA036978 will be administered at protocol defined dose.

Standard disease-directed therapy

Drug

A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Primary outcomes

  1. Number of participants with Dose Limiting Toxicities (DLT)s in Part 1

    Time frame: Up to 28 days

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

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

    Time frame: Up to approximately 2 years

    Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.

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

    Time frame: Up to approximately 2 years

    Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.

Secondary outcomes

  1. Pharmacokinetics Parameter: Cmax of INCA036978

    Time frame: Up to approximately 2 years

    Defined as maximum observed plasma concentration of INCA036978.

  2. Pharmacokinetics Parameter: Tmax of INCA036978

    Time frame: Up to approximately 2 years

    Defined as the time to reach the maximum plasma concentration of INCA036978.

  3. Pharmacokinetics Parameter: Cmax,ss of INCA036978

    Time frame: Up to approximately 2 years

    Defined as the maximum observed plasma concentration at steady state of INCA036978.

  4. Pharmacokinetics Parameter: Cmin,ss of INCA036978

    Time frame: Up to approximately 2 years

    Defined as the minimum observed plasma concentration at steady state of INCA036978.

  5. Pharmacokinetics Parameter: AUC(0-t) of INCA036978

    Time frame: Up to approximately 2 years

    Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036978.

  6. Pharmacokinetics Parameter: AUC 0-∞ of INCA036978

    Time frame: Up to approximately 2 years

    Defined as the area under the concentration-time curve from 0 to infinity of INCA036978.

  7. Pharmacokinetics Parameter: CL/F of INCA036978

    Time frame: Up to approximately 2 years

    Defined as the apparent clearance of INCA036978.

  8. Pharmacokinetics Parameter: Vz/F of INCA036978

    Time frame: Up to approximately 2 years

    Defined as the apparent volume of distribution of INCA036978.

  9. Pharmacokinetics Parameter: t1/2 of INCA036978

    Time frame: Up to approximately 2 years

    Defined as the apparent terminal phase disposition half-life of INCA036978.

  10. For participants with myelofibrosis (MF): Percentage of participants achieving spleen volume reduction as defined in the protocol

    Time frame: Week 12 and Week 24

    Defined as percentage of participants with a protocol defined spleen volume reduction.

  11. For participants with MF and anemia: Anemia Response as defined in the protocol

    Time frame: Up to approximately 2 years

    For non transfusion-dependent (TD) participants: An Hb increase relative to baseline as defined in the protocol if non-TD at baseline. For TD participants: Achieving transfusion independency (TI) as defined in the protocol.

  12. For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol.

    Time frame: Up to approximately 2 years

    Peripheral blood count remission as defined by the protocol.

  13. For participants with essential thrombocythemia (ET): Peripheral blood count remission as defined by the protocol.

    Time frame: Up to approximately 2 years

    Peripheral blood count remission as defined by the protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 2, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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