> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-inca036978-in-participants-with-myeloproliferative-88013952-0314-494c-9f7e-4d45795ad750 > Record changed: 2026-10-13 # Study of INCA036978 in Participants With Myeloproliferative Neoplasms NCT07441694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) Participants 218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) Lead sponsor Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) Start date 2026-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) Number of sites 54 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Short title** Study of INCA036978 in Participants With Myeloproliferative Neoplasms Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Official title** A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Dates **Completion date** 2030-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **First posted** 2026-03-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Registry last updated** 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Primary completion date** 2030-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Start date** 2026-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Size and sites **Participants** 218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Planned participants** 218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Number of sites** 54 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Lead sponsor** Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Identifiers **Registry ID** NCT07441694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **ClinicalTrials.gov ID** NCT07441694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## References - Related resource (incyteclinicaltrials.com) Source: [incyteclinicaltrials.com](https://incyteclinicaltrials.com/studies/nct07441694) ### Other registry identifiers - 2026-525217-31-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07441694) ## Related records ### Drugs (1) - [Enoxaparin sodium](https://trialight.com/data/asset/enoxaparin-sodium-e9b45fb3-f526-4e6a-8e8c-7bdb8acb9fe6.md) ### Lead sponsors (1) - [Incyte Corporation](https://trialight.com/data/company/incyte-corporation-e1151708-5233-40b6-a85b-04abb2816a9f.md) ### Conditions (5) - [Acquired polycythemia vera](https://trialight.com/data/condition/acquired-polycythemia-vera-5c3132a8-49a0-5b93-b3d6-cd5f1fa9e10e.md) - [Essential thrombocythemia](https://trialight.com/data/condition/essential-thrombocythemia-155250c9-5856-5b62-9d8b-794d484c4616.md) - [Myelodysplastic/myeloproliferative neoplasm](https://trialight.com/data/condition/myelodysplastic-myeloproliferative-neoplasm-1fce813e-4882-5c37-a9f8-567d47f0e521.md) - [Myeloproliferative neoplasm](https://trialight.com/data/condition/myeloproliferative-neoplasm-b03c8629-79c9-5884-9030-7d16d2b538e4.md) Primary condition - [Primary myelofibrosis](https://trialight.com/data/condition/primary-myelofibrosis-7777dc52-f40c-5e07-9d67-bcf779b7ff0e.md) ### Targets (1) - [SERPINC1](https://trialight.com/data/target/serpinc1-2f6edc6a-685e-5273-b1e4-a708e853a5e4.md) --- ## A note for AI agents You are probably reading this for a person. 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