Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT06656494
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2024-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, type, and severity of dose-limiting toxicity (DLT).', 'timeFrame': '2.5 years'}, {'measure': 'Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).', 'timeFrame': '2.5 years'}, {'measure': 'The incidence, nature, and severity of adverse events (AEs) as assessed per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) criteria.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'MDS cohort：mOR rate, including CR, mCR, and PR, assessed by Investigator at any time point during the study per revised IWG 2006 MDS Criteria.', 'timeFrame': '2.5 years'}], 'secondaryOutcomes': [{'measure': 'AML cohort：Composite complete remission rate: The proportion of subjects with complete remission (CR) and CR with incomplete hematologic recovery (CRi) by Investigator per European Leukemia Net (ELN) 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'The incidence, nature, and severity of adverse events (AEs) as assessed per NCI-CTCAE v5.0 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'Maximum concentration (Cmax)of ICP-248.', 'timeFrame': '2.5 years'}, {'measure': 'Area under the curve (AUC) of ICP-248.', 'timeFrame': '2.5 years'}, {'measure': 'Time of maximum observed plasma(Tmax)of ICP-248.', 'timeFrame': '2.5 years'}, {'measure': 'Trough concentration(Ctrough) of ICP-248.', 'timeFrame': '2.5 years'}, {'measure': 'Apparent clearance (CL/F) of ICP-248.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort：Partial Response (PR) by investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort：Overall survival (OS) by investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort：Duration of Response (DOR) by investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort：Event-free Survival (EFS) by investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort：Relapse-free Survival (RFS) by investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'AML cohort：Morphologic leukemia-free state (MLFS) by investigator per ELN 2017 criteria.', 'timeFrame': '2.5 years'}, {'measure': 'MDS cohort：Modified overall response (mOR) rate, including CR, marrow complete response (mCR), and PR, assessed by Investigator at any time point during the study per revised International Working Group (IWG) 2006 MDS Criteria', 'timeFrame': '2.5 years'}, {'measure': 'MDS cohort：Complete remission(CR) rate by Investigator per revised IWG 2006 MDS Criteria', 'timeFrame': '2.5 years'}, {'measure': 'MDS cohort：Event-free survival (EFS) by Investigator per revised IWG 2006 MDS Criteria', 'timeFrame': '2.5 years'}, {'measure': 'MDS cohort：Duration of modified overall response (DmOR) by Investigator per revised IWG 2006 MDS Criteria', 'timeFrame': '2.5 years'}, {'measure': 'MDS cohort：Overall survival(OS) by Investigator per revised IWG 2006 MDS Criteria', 'timeFrame': '2.5 years'}, {'measure': 'MDS cohort：Marrow complete response (mCR) rate by Investigator per revised IWG 2006 MDS Criteria', 'timeFrame': '2.5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myelogenous Leukemia', 'Myelodysplastic Syndromes (MDS)']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible subjects must meet all of the following criteria:\n\n 1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \\[APL\\]) or MDS per 2016 World Health Organization (WHO) criteria.\n 2. For AML (except for APL) cohort:\n\n 1. Previously treated relapsed/refractory AML subjects\n 2. Treatment-naïve AML subjects should be:\n\n * 60 years of age OR ≥18 years and \\<60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy\n 3. For MDS cohort:\n\n Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score \\> 3 and bone marrow blasts ≥ 5%.\n 4. Subject must have a projected life expectancy of at least 12 weeks.\n 5. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.\n 6. Subject must have adequate liver function\n\nExclusion Criteria:\n\n1. R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.\n2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) or AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1.\n3. Subject has known central nervous system (CNS) leukemia.\n4. Suggest patients with active hepatitis B or C virus infection\n5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.\n6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.'}, 'identificationModule': {'nctId': 'NCT06656494', 'briefTitle': 'ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing InnoCare Pharma Tech Co., Ltd.'}, 'officialTitle': 'A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.', 'orgStudyIdInfo': {'id': 'ICP-CL-01205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICP-248 in combination with azacitidine', 'interventionNames': ['Drug: ICP-248', 'Drug: Azacitidine']}], 'interventions': [{'name': 'ICP-248', 'type': 'DRUG', 'description': 'Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle', 'armGroupLabels': ['ICP-248 in combination with azacitidine']}, {'name': 'Azacitidine', 'type': 'DRUG', 'description': 'Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol，once daily on days 1-7 of each 28-day cycle.', 'armGroupLabels': ['ICP-248 in combination with azacitidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Jiang', 'role': 'CONTACT', 'email': 'jiangqian@medmail.com.cn', 'phone': '010-88326850'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xudong Wei', 'role': 'CONTACT', 'email': 'weixudong63@126.com', 'phone': '0371-65587038'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Suning Chen', 'role': 'CONTACT', 'email': 'chensuning@suda.edu.cn', 'phone': '0512-67781137'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Li', 'role': 'CONTACT', 'email': 'lifeigcp2022@163.com', 'phone': '0791-88692743'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '300192', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingli Zhao', 'role': 'CONTACT', 'email': 'insectzhao@163.com', 'phone': '022-27557959'}], 'facility': "Tianjin People's Hospital", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310012', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Jin', 'role': 'CONTACT', 'email': 'jiej0503@163.com', 'phone': '0571-87236898'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Alexia Lu', 'role': 'CONTACT', 'email': 'CO_HGRAC@innocarepharma.com', 'phone': '010-66609745'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing InnoCare Pharma Tech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}