Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT07283835
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C040358', 'term': 'dodecyl maltoside'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2025-12-06', 'studyFirstSubmitQcDate': '2025-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DOR)', 'timeFrame': '36 months', 'description': 'Time from first documented objective response to disease progression or death from any cause.'}, {'measure': 'Assess high-grade reoccurrence free survival (RFS)', 'timeFrame': '36 months', 'description': 'Time from first treatment to first recurrence of high-grade disease or death from any cause.'}, {'measure': 'Assess progression free survival (PFS)', 'timeFrame': '36 months', 'description': 'Time from first treatment to tumor progression or death from any cause.'}, {'measure': 'Complete response rate at 12, 24, and 36 months', 'timeFrame': 'Assessed at 12, 24, and 36 months', 'description': 'Proportion of patients achieving complete response at 12, 24, and 36 months.'}, {'measure': 'Overall survival rate at 36 months', 'timeFrame': '36 months', 'description': 'Proportion of patients alive at 36 months.'}, {'measure': 'Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE)', 'timeFrame': '36 months', 'description': 'Safety is evaluated based on NCI-CTCAE v5.0 criteria. This includes incidence and severity of all adverse events (AE), serious adverse events (SAE), and abnormal laboratory values.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-grade Ta papillary disease', 'high-grade T1 papillary disease', 'carcinoma in situ', 'Bacillus-Calmette-Guerin unresponsive'], 'conditions': ['Non Muscle Invasive Bladder Cancer', 'High-grade Ta/ T1 Papillary Disease Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy and safety of CG0070 injection in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.', 'detailedDescription': 'An open-label trial designed to evaluate CG0070 + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible for participation in this trial, the patient must:\n\n1. Be ≥18 years of age on day of signing informed consent.\n\n \\- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease.\n2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n3. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.\n4. Demonstrate adequate organ function.\n5. Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.\n6. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.\n\nExclusion Criteria:\n\n1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.\n2. History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.\n3. Has received systemic anti-cancer therapy, including investigational agents.\n4. Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.\n5. Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.\n6. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of CG0070.'}, 'identificationModule': {'nctId': 'NCT07283835', 'briefTitle': 'Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lepu Biopharma Co., Ltd.'}, 'officialTitle': 'A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of CG0070 Injection in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'CG0070-II-CIS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CG0070', 'description': 'Patients with CIS with or without HG Ta/T1 papillary disease. CG0070 will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly for specific schedule per protocol.', 'interventionNames': ['Biological: CG0070', 'Other: DDM']}], 'interventions': [{'name': 'CG0070', 'type': 'BIOLOGICAL', 'otherNames': ['Cretostimogene'], 'description': 'Engineered Oncolytic Adenovirus', 'armGroupLabels': ['CG0070']}, {'name': 'DDM', 'type': 'OTHER', 'otherNames': ['n-dodecyl-B-D-maltoside'], 'description': 'Transduction-enhancing agent', 'armGroupLabels': ['CG0070']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhisong He', 'role': 'CONTACT', 'email': 'wyj7074@sohu.com', 'phone': '86-13141316696'}], 'facility': 'Peking University First Hospital (First Clinical Medical School of Peking University)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Yuan', 'role': 'CONTACT', 'email': '775059475@qq.com', 'phone': '86-23-65456552'}], 'facility': 'Chongqing University Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Chen', 'role': 'CONTACT', 'email': 'fjszlyyjgb@163.com', 'phone': '86-591-62752500'}], 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kai Rao', 'role': 'CONTACT', 'email': 'lisu@sysucc.org.cn', 'phone': '86-20-87343990'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Zhang', 'role': 'CONTACT', 'email': 'whuniongcp@126.com', 'phone': '86-27-85726685'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shusuan Jiang', 'role': 'CONTACT', 'email': 'lkunyan@163.com', 'phone': '86-731-88651269'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongqian Guo', 'role': 'CONTACT', 'email': 'dr.ghq@163.com', 'phone': '86-25-83105910'}], 'facility': 'The Affiliated Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianbin Bi', 'role': 'CONTACT', 'email': 'zhouliping750825@163.com', 'phone': '86-24-83283392'}], 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Benkang Shi', 'role': 'CONTACT', 'email': 'qlyygcp_ms@qiluhospital.com', 'phone': '86-531-82165412'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Danfeng Xu', 'role': 'CONTACT', 'email': 'xdf12036@rjh.com.cn', 'phone': '86-21-63085543'}], 'facility': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dinɡwei Ye, M.D.', 'role': 'CONTACT', 'email': 'fuscc2012@163.com', 'phone': '86-21-64175590'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Peng', 'role': 'CONTACT', 'email': 'lzheng2005618@aliyun.com', 'phone': '86-28-85423655'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300211', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hailong Hu', 'role': 'CONTACT', 'email': 'huhailong@tmu.edu.cn', 'phone': '86-13920223774'}], 'facility': 'The Second Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Baiye Jin', 'role': 'CONTACT', 'email': 'inbaive1964@ziu.edu.cn', 'phone': '86-13958027659'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hang Huang', 'role': 'CONTACT', 'email': 'fuscc2012@163.com', 'phone': '86-13857727395'}], 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Program Director', 'role': 'CONTACT', 'email': 'clinicaltrials@lepubiopharma.com', 'phone': '86-21-61637960'}], 'overallOfficials': [{'name': 'Dinɡwei Ye, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lepu Biopharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}