Study of INCA036978 in Participants With Myeloproliferative Neoplasms

NCT07441694
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
218
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Lead sponsor
Incyte Corporation
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Start date
2026-05-11
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Number of sites
54
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Summary
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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Short title
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
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Official title
A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-05-24
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First posted
2026-03-02
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Registry last updated
2026-07-22
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Primary completion date
2030-05-24
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Start date
2026-05-11
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Participants
218
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Participant count basis
Estimated
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Planned participants
218
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Protocol amendments
0
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Number of sites
54
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Registry sponsor category
Industry
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Lead sponsor
Incyte Corporation
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07441694
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ClinicalTrials.gov ID
NCT07441694
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with Dose Limiting Toxicities (DLT)s in Part 1

    Timeframe: 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)

    Timeframe: 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

    Timeframe: Up to approximately 2 years

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

  1. Pharmacokinetics Parameter: Cmax of INCA036978

    Timeframe: Up to approximately 2 years

    Defined as maximum observed plasma concentration of INCA036978.

  2. Pharmacokinetics Parameter: Tmax of INCA036978

    Timeframe: Up to approximately 2 years

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

  3. Pharmacokinetics Parameter: Cmax,ss of INCA036978

    Timeframe: Up to approximately 2 years

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

  4. Pharmacokinetics Parameter: Cmin,ss of INCA036978

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Up to approximately 2 years

    Defined as the apparent clearance of INCA036978.

  8. Pharmacokinetics Parameter: Vz/F of INCA036978

    Timeframe: Up to approximately 2 years

    Defined as the apparent volume of distribution of INCA036978.

  9. Pharmacokinetics Parameter: t1/2 of INCA036978

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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.

    Timeframe: 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.

    Timeframe: Up to approximately 2 years

    Peripheral blood count remission as defined by the protocol.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.

Sources for eligibility
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  • University of Alabama At BirminghamBirmingham, United StatesNot yet recruiting
  • City of Hope-Lennar Foundation Cancer CenterIrvine, United StatesNot yet recruiting
  • Usc Norris Comprehensive Cancer CenterLos Angeles, United StatesNot yet recruiting
  • UCLA Medical Hematology & OncologyLos Angeles, United StatesNot yet recruiting
  • Yale Cancer CenterNew Haven, United StatesNot yet recruiting
  • University of MiamiMiami, United StatesNot yet recruiting
  • Moffitt Cancer CenterTampa, United StatesNot yet recruiting
  • Winship Cancer Institute of Emory UniversityAtlanta, United StatesRecruiting
  • John Hopkins HospitalBaltimore, United StatesNot yet recruiting
  • Massachusetts General HospitalBoston, United StatesNot yet recruiting
  • Washington University School of MedicineSt Louis, United StatesNot yet recruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesNot yet recruiting
  • Mount Sinai School of MedicineNew York, United StatesNot yet recruiting
  • Weill Cornell MedicineNew York, United StatesNot yet recruiting
  • University of North Carolina At Chapel HillChapel Hill, United StatesNot yet recruiting
  • Levine Cancer InstituteCharlotte, United StatesNot yet recruiting
  • Duke University Medical Center, Department of Hematologic Malignancies and Cellular TherapyDurham, United StatesNot yet recruiting
  • Cleveland ClinicCleveland, United StatesNot yet recruiting
  • Ohio State UniversityColumbus, United StatesRecruiting
  • Tristar Bmt/TctoNashville, United StatesRecruiting
  • University of Texas M. D. Anderson Cancer CenterHouston, United StatesNot yet recruiting
  • Huntsman Cancer InstituteSalt Lake City, United StatesNot yet recruiting
  • Medical College of WisconsinMilwaukee, United StatesNot yet recruiting
  • Concord General Repatriation HospitalConcord, AustraliaRecruiting
  • Royal North Shore HospitalSt Leonards, AustraliaRecruiting

And 29 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2026-525217-31-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (5)

Targets (1)