Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-10 @ 9:29 PM
Study NCT ID:
NCT04492293
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2020-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 6 months', 'description': 'Objective Response Rate'}], 'secondaryOutcomes': [{'measure': 'DOR', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 6 months', 'description': 'Duration of response'}, {'measure': 'DCR', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 6 months', 'description': 'Disease Control Rate'}, {'measure': 'PFS', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 6 months', 'description': 'Progression Free Survival'}, {'measure': 'OS', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 1 months', 'description': 'Overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Urothelial Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.', 'detailedDescription': 'bladder urothelial cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria：\n\n1. Signed the ICF and Age ≥ 18 years old, either sex.\n2. ECOG ≤ 1.\n3. Life expectancy of at least 3 months.\n4. Histologically confirmed unresectable or metastatic bladder urothelial cancinoma.\n5. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1\n\nExclusion Criteria:\n\n1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.\n2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.'}, 'identificationModule': {'nctId': 'NCT04492293', 'briefTitle': 'An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing InnoCare Pharma Tech Co., Ltd.'}, 'officialTitle': 'A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.', 'orgStudyIdInfo': {'id': 'ICP-CL-00302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICP-192', 'description': 'ICP-192', 'interventionNames': ['Drug: ICP-192']}], 'interventions': [{'name': 'ICP-192', 'type': 'DRUG', 'description': 'ICP-192 is a white, round, uncoated table', 'armGroupLabels': ['ICP-192']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chaozhao Liang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100035', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zisong He', 'role': 'CONTACT'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lijun Chen', 'role': 'CONTACT'}], 'facility': "The fifth Medical Center of People's Liberation Army General Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Guo', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '010-88196348'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiyang He', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '730030', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Yang', 'role': 'CONTACT'}], 'facility': 'Lanzhou University Second Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Chen', 'role': 'CONTACT'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Zhang', 'role': 'CONTACT'}], 'facility': 'Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaogang Wang', 'role': 'CONTACT'}], 'facility': 'Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqing Han', 'role': 'CONTACT'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuhua Huang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Suzhou University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '130021', 'city': 'Jilin', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ziling Liu', 'role': 'CONTACT'}], 'facility': 'The First Hospital of JiLin University', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'zip': '110801', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Hu', 'role': 'CONTACT'}], 'facility': 'Liaoning Cancer Hospital & Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Benkang Shi', 'role': 'CONTACT'}], 'facility': 'Shandong University Qilu Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Danfeng Xu', 'role': 'CONTACT'}], 'facility': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoming Cao', 'role': 'CONTACT'}], 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liao Hong', 'role': 'CONTACT'}], 'facility': 'Sichuan Cancer Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Yao', 'role': 'CONTACT'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300211', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hailong Hu', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liping Xie', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaoxing Zhu', 'role': 'CONTACT'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiying Dong', 'role': 'CONTACT'}], 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jun Guo', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '010-88196348'}], 'overallOfficials': [{'name': 'Jun Guo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing InnoCare Pharma Tech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}