Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-02-17 @ 7:22 PM
Study NCT ID:
NCT04014205
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2019-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729508', 'term': 'orelabrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-07-09', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 Dose Escalation：The maximum tolerated dose (MTD)', 'timeFrame': 'Incidence of dose limiting toxicities (DLTs) up to 28 days', 'description': 'To determine the maximum tolerated dose (MTD)'}, {'measure': 'Part 2 Dose Expansion：ORR', 'timeFrame': 'Up to 2 years', 'description': 'To assess anti-tumor activity of Orelabrutinib (ICP-022) in Patients with B-cell malignancies including r/r MCL, r/r FL, r/r MZL and CLL/SLL with/without prior treatment.'}], 'secondaryOutcomes': [{'measure': 'Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]', 'timeFrame': 'Up to 2 years', 'description': 'The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed'}, {'measure': 'Part 1 Dose Escalation：ORR', 'timeFrame': 'Up to 2 years', 'description': 'Objective response rate'}, {'measure': 'Part 1 Dose Escalation：T1/2', 'timeFrame': 'Up to 2 years', 'description': 'Elimination half-life'}, {'measure': 'Part 2 Dose Expansion：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]', 'timeFrame': 'Up to 2 years', 'description': 'The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed'}, {'measure': 'Part 2 Dose Expansion：DOR', 'timeFrame': 'Up to 2 years', 'description': 'Duration of response'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Part 1：r/r B-cell Malignancies', 'Part 2：B-cell Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed Informed Consent.\n2. Age ≥ 18 years.\n3. Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.\n\n Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.\n4. Life expectancy (in the opinion of the investigator) of ≥ 4 months.\n5. ECOG performance status of 0 \\~1.\n6. Must have adequate organ function.\n7. Negative test results for HBV (\\[HBsAg (-)\\] and non-active HBV or HCV infection\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding or intending to become pregnant during the study.\n2. Prior treatment with systemic immunotherapeutic agents.\n3. Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.\n4. Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.\n5. History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.\n6. Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.\n7. Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.\n8. Active uncontrolled infections.\n9. Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.\n10. Unresolved toxicities from prior anti-cancer therapy.\n11. Medically apparent CNS lymphoma or leptomeningeal disease.\n12. Current or previous history of CNS disease.\n13. Major surgery or significant traumatic injury \\< 28 days prior to the first dose of the study drug.\n14. Patients with another invasive malignancy in the last 2 years.\n15. Significant cardiovascular disease or active pulmonary disease.\n16. Received systemic immunosuppressive medications.'}, 'identificationModule': {'nctId': 'NCT04014205', 'briefTitle': 'A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing InnoCare Pharma Tech Co., Ltd.'}, 'officialTitle': "A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies", 'orgStudyIdInfo': {'id': 'ICP-CL-00107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation', 'description': 'Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL', 'interventionNames': ['Drug: Orelabrutinib (ICP-022)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Dose Expansion', 'description': 'Arm 1: Patients with r/r MCL\n\nArm 2: Patients with other types of B-cell malignancies, including:\n\n* CLL/SLL with/without prior treatment\n* r/r FL\n* r/r MZL', 'interventionNames': ['Drug: Orelabrutinib (ICP-022)']}], 'interventions': [{'name': 'Orelabrutinib (ICP-022)', 'type': 'DRUG', 'description': 'ICP-022 The drug product is a white, round, uncoated tablet', 'armGroupLabels': ['Part 1 Dose Escalation', 'Part 2 Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054-4502', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic-Mayo Clinic Hospital-Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801-1824', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Cancer Network - Good Samaritan Hospital Location', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Hematology Oncology Medical Group, Inc.', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'The Oncology Institute of Hope & Innovation', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists (FCS) South', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '34607', 'city': 'Weeki Wachee', 'state': 'Florida', 'country': 'United States', 'facility': 'Asclepes Research Centers - Weeki Wachee', 'geoPoint': {'lat': 28.51555, 'lon': -82.57288}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Neurology - Rolling Meadows Office', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Orchard Healthcare Research Inc.', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '46526', 'city': 'Goshen', 'state': 'Indiana', 'country': 'United States', 'facility': 'Goshen Center for Cancer Care', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': "Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)", 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21401-3093', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Medical Center (AAMC) Oncology and Hematology', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - 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Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Guthrie Cancer Center', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '57201', 'city': 'Watertown', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Prairie Lakes Cancer Center', 'geoPoint': {'lat': 44.89941, 'lon': -97.11507}}, {'zip': '37404-1130', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology - Chattanooga Oncology & Hematology Associates', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37909-1327', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Cancer Specialists', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37203-1625', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute - Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '99201', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Medical Oncology Associates PS (dba Summit Cancer Centers)', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Cherkasy', 'country': 'Ukraine', 'facility': 'Cherkassy Regional Oncology Center', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'city': 'Khmelnytskyi', 'country': 'Ukraine', 'facility': 'Khmelnytskyi Regional Hospital', 'geoPoint': {'lat': 49.41835, 'lon': 26.97936}}, {'city': 'Kropyvnytskyi', 'country': 'Ukraine', 'facility': "St. Luke's Hospital - 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