Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05372120
Status:
UNKNOWN
Last Update Posted:
2023-01-04
First Post:
2022-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
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': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2022-05-08', 'studyFirstSubmitQcDate': '2022-05-08', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 6 months', 'description': 'Progression free survival is the time period from start of study medication till the disease progression or death, whichever occurs first.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 1 year', 'description': 'OS is the time period from start of study medication untill death from any cause.'}], 'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 6 months', 'description': 'ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DOR)', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 6 months', 'description': 'DOR is time interval from the first date that criteria for complete response or partial response are met to the first date of progression of disease'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From the time of first dose until objective disease progression, an average of 6 months', 'description': 'DCR based on assessment of confirmed Complete response (CR), partial response (PR) or stable disease(SD) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.'}, '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. Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration\n5. Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration\n6. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.\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.\n3. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.'}, 'identificationModule': {'nctId': 'NCT05372120', 'briefTitle': 'A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing InnoCare Pharma Tech Co., Ltd.'}, 'officialTitle': 'A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations', 'orgStudyIdInfo': {'id': 'ICP-CL-00304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICP-192', 'description': '20 mg once daily', 'interventionNames': ['Drug: ICP-192']}], 'interventions': [{'name': 'ICP-192', 'type': 'DRUG', 'description': 'ICP-192 is a round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression', 'armGroupLabels': ['ICP-192']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233000', 'city': 'Bengbu', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang Hao', 'role': 'CONTACT'}], 'facility': 'The first affiliated hospital of bengbu medical college', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yifu He', 'role': 'CONTACT'}], 'facility': 'Anhui Provincal Cancer Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Cancer Hospital.Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Sun', 'role': 'CONTACT'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaojun Lin', 'role': 'CONTACT'}], 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juntao Ran', 'role': 'CONTACT'}, {'name': 'Ting Wang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Li', 'role': 'CONTACT'}], 'facility': 'Affiliated Cancer Hospital and Institute of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingqing Cai', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '50000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoying Xue', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tongsen Zheng', 'role': 'CONTACT'}], 'facility': 'Harbin Medical University cancer hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shundong Cang', 'role': 'CONTACT'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingya Li', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Suxia Luo', 'role': 'CONTACT'}], 'facility': 'Henan Tumor Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanru Qin', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kunyu Yang', 'role': 'CONTACT'}], 'facility': 'Union Hospital Toji Medical College Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hu Guangyuan', 'role': 'CONTACT'}], 'facility': 'Tongji Hospital Tongji Medical College of HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liaoyang Shen', 'role': 'CONTACT'}], 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenyang Liu', 'role': 'CONTACT'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cuihong Jiang', 'role': 'CONTACT'}], 'facility': 'Hunan Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '226361', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Yang', 'role': 'CONTACT'}], 'facility': 'Nantong Cancer Hospital', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '214122', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Mao', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Jiangnan University', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiujiang Cui', 'role': 'CONTACT'}], 'facility': 'The first hospital of jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'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': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Man Hu', 'role': 'CONTACT'}], 'facility': 'Shandong Provincial Institute of Cancer Prevention and Treatment', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yufeng Cheng', 'role': 'CONTACT'}], 'facility': 'QiLu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '276000', 'city': 'Linyi', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhua Shi', 'role': 'CONTACT'}], 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '20000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guipei Zhu', 'role': 'CONTACT'}], 'facility': "Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianshu Liu', 'role': 'CONTACT'}], 'facility': 'Zhongshan Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200135', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Guo', 'role': 'CONTACT'}], 'facility': 'Shanghai East Hospital', 'geoPoint': {'lat': 31.22222, 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People's Hospital of Yibin City", 'geoPoint': {'lat': 28.7593, 'lon': 104.63994}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peiguo Wang', 'role': 'CONTACT'}], 'facility': 'Tianjin medical university cancer institute&hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongming Pan', 'role': 'CONTACT'}], 'facility': 'Shaoyifu Hospital of Zhejiang University Medical College', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meiyu Fang', 'role': 'CONTACT'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Minghua Ge', 'role': 'CONTACT'}], 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ye Guo', 'role': 'CONTACT', 'email': 'pattrickguo@gmail.com', 'phone': '13501678472'}], 'overallOfficials': [{'name': 'Ye Guo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai East Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing InnoCare Pharma Tech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}