Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:27 AM
Study NCT ID:
NCT07441694
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}, {'id': 'D011087', 'term': 'Polycythemia Vera'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-05-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Dose Limiting Toxicities (DLT)s in Part 1', 'timeFrame': 'Up to 28 days', 'description': 'Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.'}, {'measure': 'Number of participants with Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to approximately 2 years', 'description': '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.'}, {'measure': 'Number of participants with TEAEs leading to dose modification or discontinuation', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics Parameter: Cmax of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as maximum observed plasma concentration of INCA036978.'}, {'measure': 'Pharmacokinetics Parameter: Tmax of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as the time to reach the maximum plasma concentration of INCA036978.'}, {'measure': 'Pharmacokinetics Parameter: Cmax,ss of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as the maximum observed plasma concentration at steady state of INCA036978.'}, {'measure': 'Pharmacokinetics Parameter: Cmin,ss of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as the minimum observed plasma concentration at steady state of INCA036978.'}, {'measure': 'Pharmacokinetics Parameter: AUC(0-t) of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036978.'}, {'measure': 'Pharmacokinetics Parameter: AUC 0-∞ of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as the area under the concentration-time curve from 0 to infinity of INCA036978.'}, {'measure': 'Pharmacokinetics Parameter: CL/F of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as the apparent clearance of INCA036978.'}, {'measure': 'Pharmacokinetics Parameter: Vz/F of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as the apparent volume of distribution of INCA036978.'}, {'measure': 'Pharmacokinetics Parameter: t1/2 of INCA036978', 'timeFrame': 'Up to approximately 2 years', 'description': 'Defined as the apparent terminal phase disposition half-life of INCA036978.'}, {'measure': 'For participants with myelofibrosis (MF): Percentage of participants achieving spleen volume reduction as defined in the protocol', 'timeFrame': 'Week 12 and Week 24', 'description': 'Defined as percentage of participants with a protocol defined spleen volume reduction.'}, {'measure': 'For participants with MF and anemia: Anemia Response as defined in the protocol', 'timeFrame': 'Up to approximately 2 years', 'description': '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.'}, {'measure': 'For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol.', 'timeFrame': 'Up to approximately 2 years', 'description': 'Peripheral blood count remission as defined by the protocol.'}, {'measure': 'For participants with essential thrombocythemia (ET): Peripheral blood count remission as defined by the protocol.', 'timeFrame': 'Up to approximately 2 years', 'description': 'Peripheral blood count remission as defined by the protocol.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myeloproliferative Neoplasms', 'Myelofibrosis', 'Essential thrombocythemia', 'Polycythemia Vera'], 'conditions': ['Myeloproliferative Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://incyteclinicaltrials.com/studies/nct07441694', 'label': 'Study of INCA036978 in Participants With Myeloproliferative Neoplasms'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).\n* Participants with MF, PV and ET as defined in the protocol.\n\nExclusion Criteria:\n\n* Presence of any hematological malignancy other than MF, PV, or ET.\n* Malignancy within the last 3 years prior to enrollment.\n* Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.\n* Clinically significant or uncontrolled cardiac disease.\n* Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.\n* Laboratory values outside the Protocol-defined ranges.\n* Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.\n* Presence of chronic or current active infectious disease requiring systemic treatment.\n* Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.\n* Prior radiation therapy within 28 days before the first dose of study treatment.\n\nOther protocol-defined Inclusion/Exclusion Criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07441694', 'briefTitle': 'Study of INCA036978 in Participants With Myeloproliferative Neoplasms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms', 'orgStudyIdInfo': {'id': 'INCA036978-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1a: Dose Escalation', 'description': 'INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s).', 'interventionNames': ['Drug: INCA036978']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1b: Dose Escalation', 'description': 'INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s).', 'interventionNames': ['Drug: INCA036978', 'Drug: Standard disease-directed therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2a: Dose Expansion', 'description': 'INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1', 'interventionNames': ['Drug: INCA036978']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2b: Dose Expansion', 'description': 'INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1.', 'interventionNames': ['Drug: INCA036978', 'Drug: Standard disease-directed therapy']}], 'interventions': [{'name': 'INCA036978', 'type': 'DRUG', 'description': 'INCA036978 will be administered at protocol defined dose.', 'armGroupLabels': ['Part 1a: Dose Escalation', 'Part 1b: Dose Escalation', 'Part 2a: Dose Expansion', 'Part 2b: Dose Expansion']}, {'name': 'Standard disease-directed therapy', 'type': 'DRUG', 'description': 'A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.', 'armGroupLabels': ['Part 1b: Dose Escalation', 'Part 2b: Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'City of Hope-Lennar Foundation Cancer Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Usc Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'UCLA Medical Hematology & Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'John Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63108', 'city': 'St Louis', 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