Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-01 @ 6:27 AM
Study NCT ID:
NCT07008118
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Dose Limiting Toxicities (DLTs)', '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 and 90 days', 'description': '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.'}, {'measure': 'Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with TEAEs leading to dose modification or discontinuation', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Number of participants with TEAEs leading to dose modification or discontinuation.'}, {'measure': '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)', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.'}, {'measure': 'Participants with essential thrombocythemia (ET): Response using the revised IWG-MRT and ELN response criteria for ET', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.'}, {'measure': 'Participants with myelodysplastic syndrome (MDS)/MPN: Response using the revised IWG-MRT response criteria for MDS/MPN', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the percentage of participants with Response using the revised IWG-MRT response criteria.'}, {'measure': 'Participants with symptomatic anemia: Anemia response', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Anemia response as defined in the protocol.'}, {'measure': 'Participants with spleen volume (SV) ≥ 450 mL at baseline: Percentage of participants achieving spleen volume reduction of ≥ 35% (SVR35)', 'timeFrame': 'Week 12 and Week 24', 'description': 'Defined as percentage of participants with a protocol defined Spleen Volume Reduction of ≥ 35% (SVR35).'}, {'measure': 'Participants with SV ≥ 450 mL at baseline: Percentage of participants achieving spleen volume reduction of ≥ 25% (SVR25)', 'timeFrame': 'Week 12 and Week 24', 'description': 'Defined as percentage of participants with a protocol defined Spleen Volume Reduction of ≥ 25% (SVR25).'}, {'measure': 'Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS)', 'timeFrame': 'Week 12 and Week 24', 'description': 'Defined as the percentage of participants achieving ≥ 50% reduction from baseline of TSS.'}, {'measure': 'Mean change from baseline in TSS', 'timeFrame': 'Week 12 and Week 24', 'description': 'Mean change of TSS from baseline.'}, {'measure': 'Pharmacokinetics Parameter (PK): Cmax of INCA035784', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as maximum observed plasma concentration of INCA035784.'}, {'measure': 'Pharmacokinetics Parameter: Tmax of INCA035784', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the time to reach the maximum plasma concentration of INCA035784.'}, {'measure': 'Pharmacokinetics Parameter: Cmin of INCA035784', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the minimum observed plasma concentration of INCA035784.'}, {'measure': 'Pharmacokinetics Parameter: AUC(0-t) of INCA035784', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the area under the concentration-time curve up to the last measurable concentration of INCA035784.'}, {'measure': 'Pharmacokinetics Parameter: AUC 0-∞ of INCA035784', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the area under the concentration-time curve from 0 to infinity of INCA035784.'}, {'measure': 'Pharmacokinetics Parameter: CL of INCA035784', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the apparent oral dose clearance of INCA035784.'}, {'measure': 'Pharmacokinetics Parameter: Vz of INCA035784', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the apparent oral dose volume of distribution of INCA035784.'}, {'measure': 'Pharmacokinetics Parameter: t1/2 of INCA035784', 'timeFrame': 'Up to approximately 2 years and 90 days', 'description': 'Defined as the apparent terminal phase disposition half-life of INCA035784.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myeloproliferative Neoplasms', 'Myelofibrosis', 'Essential thrombocythemia', 'CALR mutation'], 'conditions': ['Myeloproliferative Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.incyteclinicaltrials.com/trials/INCA035784-101', 'label': 'A study to evaluate INCA035784 in Participants With Myeloproliferative Neoplasms'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older at the time of signing the ICF\n* ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)\n* Documented CALR exon-9 mutation\n* Confirmed diagnosis of MPN according to the 2022 ICC criteria:\n\n * DIPSS+ intermediate-2/high-risk MF with prior JAKi, \\<20% blasts, and measurable spleen\n * High-risk ET with platelets \\>450×10⁹/L\n* Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET\n* No prior stem cell transplant and none planned within 6 months\n* Minimum Laboratory Requirements:\n\n * Platelet count ≥50 × 10⁹/L\n * Absolute neutrophil count ≥1 × 10⁹/L\n * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists\n * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\<2.5 × ULN\n * Total bilirubin \\<2 × ULN\n * Estimated creatinine clearance \\>45 or \\>30 mL/min (depending on study part)\n\nExclusion Criteria:\n\n* Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months\n* Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment\n* 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)\n* Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose.\n\nOther protocol-defined Inclusion/Exclusion Criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07008118', 'briefTitle': 'A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms', 'orgStudyIdInfo': {'id': 'INCA035784-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1a: Dose escalation', 'description': 'INCA035784 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.', 'interventionNames': ['Drug: INCA035784']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1b: Dose expansion', 'description': 'INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group.', 'interventionNames': ['Drug: INCA035784']}], 'interventions': [{'name': 'INCA035784', 'type': 'DRUG', 'description': 'INCA035784 will be administered at protocol defined dose.', 'armGroupLabels': ['Part 1a: Dose escalation', 'Part 1b: Dose expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic-Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Johns Hopkins University', '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': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine At Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of North Carolina At Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '78704', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Austin Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center Blood', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Huntsman Cancer Institute At University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '02109', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Macquarie University Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '05000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '03004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '06009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'centralContacts': [{'name': 'Incyte Corporation Call Center (US)', 'role': 'CONTACT', 'email': 'medinfo@incyte.com', 'phone': '1.855.463.3463'}, {'name': 'Incyte Corporation Call Center (ex-US)', 'role': 'CONTACT', 'email': 'eumedinfo@incyte.com', 'phone': '+800 00027423'}], 'overallOfficials': [{'name': 'Incyte Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}