Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 4:43 AM
Study NCT ID:
NCT06662760
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of TQB3002 in Patients With Advanced Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-10-28', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity (DLT)', 'timeFrame': 'During the first 28 days', 'description': 'DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28days) of treatment.'}, {'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'During the first 28 days', 'description': 'MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.'}], 'secondaryOutcomes': [{'measure': 'Half-life (T1/2)', 'timeFrame': 'Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration', 'description': 'Terminal half-life (T1/2)'}, {'measure': 'The area under the curve (AUC)', 'timeFrame': 'Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration', 'description': 'The area under the curve (AUC) of serum concentration of TQB3002'}, {'measure': 'Apparent Plasma Clearance (CL)', 'timeFrame': 'Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration', 'description': 'Apparent plasma clearance of TQB3002'}, {'measure': 'Apparent volume of distribution (Vz)', 'timeFrame': 'Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration', 'description': 'The ratio of the amount of TQB3002 in the body to the blood concentration'}, {'measure': 'Minimum concentration (Cmin)', 'timeFrame': 'Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration', 'description': 'Minimum observed concentration (Cmin) of TQB3002'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；\n* Age: ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；\n* Histologically or cytologically diagnosed with advanced cancers\n* Subjects with advanced malignancies who have failed standard therapy or lack effective treatment\n* Major organs are functioning well；\n* Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n* Current concomitant presence of other malignancies within 5 years prior to the first dose；\n* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy\n* Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose\n* Long-term unhealed wounds or fractures\n* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose\n* Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy\n* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder\n* Subjects with any severe and/or uncontrolled disease'}, 'identificationModule': {'nctId': 'NCT06662760', 'briefTitle': 'Clinical Trial of TQB3002 in Patients With Advanced Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers', 'orgStudyIdInfo': {'id': 'TQB3002-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB3002 Tablets', 'description': 'TQB3002 Tablets, 28 days as a treatment cycle', 'interventionNames': ['Drug: TQB3002 Tablets']}], 'interventions': [{'name': 'TQB3002 Tablets', 'type': 'DRUG', 'description': 'TQB3002 is a fourth-generation small molecule Epidermal growth factor receptor (EGFR) inhibitor, which inhibits relevant tyrosine kinase activity and intracellular phosphorylation process by competitively binding to Adenosine triphosphate (ATP) site of intracellular tyrosine kinase binding domain, thereby inhibiting EGFR downstream signaling, ultimately achieving the purpose of inhibiting tumor growth.', 'armGroupLabels': ['TQB3002 Tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510180', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qing Zhou, Doctor', 'role': 'CONTACT', 'email': 'zhouqing@gdph.org.cn', 'phone': '020-83827812'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518117', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shi Jin, Doctor', 'role': 'CONTACT', 'email': '13796600916@126.com', 'phone': '13796600916'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqiu Zhao, Doctor', 'role': 'CONTACT', 'email': '13938252350@163.com', 'phone': '13938252350'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Renhua Guo, Master', 'role': 'CONTACT', 'email': 'guorenhua@csco.ac.cn', 'phone': '13585145540'}], 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330038', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Longhua Sun, Doctor', 'role': 'CONTACT', 'email': '48570887@qq.com', 'phone': '18279110112'}, {'name': 'Jinhua Wen, Doctor', 'role': 'CONTACT', 'email': 'wenjh8606@163.com', 'phone': '13970823367'}], 'facility': 'The First Affiliated Hospital Of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengxiang Ren, Doctor', 'role': 'CONTACT', 'email': 'harry_ren@126.com', 'phone': '13816756732'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710004', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Guo, Doctor', 'role': 'CONTACT', 'email': 'guohuihappy97@163.com', 'phone': '13572824106'}], 'facility': "The Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '710061', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Yao, Doctor', 'role': 'CONTACT', 'email': 'Oncology_yao@163.com', 'phone': '13572101611'}], 'facility': "The First Affiliated Hospital of Xi'an Jiao Tong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610040', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Li, Doctor', 'role': 'CONTACT', 'phone': '13570431657'}], 'facility': 'Sichuan Cancer Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '621099', 'city': 'Mianyang', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Zhang, Doctor', 'role': 'CONTACT', 'email': '543703371@qq.com', 'phone': '15228700888'}], 'facility': 'Mianyang Central Hospital', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'zip': '650118', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Runxiang Yang, Master', 'role': 'CONTACT', 'email': '13888876721@163.com', 'phone': '13888876721'}], 'facility': 'Yunnan Cancer Hospital', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Qing Zhou, Doctor', 'role': 'CONTACT', 'email': 'zhouqing@gdph.org.cn', 'phone': '020-83827812'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}