Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-31 @ 12:26 AM
Study NCT ID:
NCT05598268
Status:
UNKNOWN
Last Update Posted:
2022-10-28
First Post:
2022-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of T3011 Administered Via Intravenously in Patients With Advanced Solid Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploring tumor immunomodulatory mechanism', 'timeFrame': 'Up to 42 days from first dose of T3011', 'description': 'Lymphocyte typing'}, {'measure': 'Exploring histological changes after IT T3011', 'timeFrame': 'Up to 42 days from first dose of T3011', 'description': 'Immunofluorescence detection'}, {'measure': 'Exploring the relationship between genetic changes and drug efficacy', 'timeFrame': 'Up to 42 days from first dose of T3011', 'description': 'Tumor tissue sequencing'}], 'primaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of escalating doses of IV T3011 in Patients with advanced malignant tumors', 'timeFrame': 'Up to 2 years from first dose of T3011', 'description': 'Incidence of AE(TEAE)'}, {'measure': 'Assess DLTs and identify the RP2D of single agent IV T3011', 'timeFrame': 'Up to 2 years from first dose of T3011', 'description': 'Incidence of DLT'}, {'measure': 'Assess safety and tolerability of T3011 intravenous administration at MTD or RP2D doses through dose extension study', 'timeFrame': 'Up to 2 years from first dose of T3011', 'description': 'Incidence of AE(TEAE)'}], 'secondaryOutcomes': [{'measure': 'Evaluate the biodistribution and viral shedding of IV T3011', 'timeFrame': 'Up to 2 years from first dose of T3011', 'description': "Measurement of T3011 in subjects' blood, urine, and saliva for biodistribution and viral shedding"}, {'measure': 'Evaluate the immunogenicity of IV T3011', 'timeFrame': 'Up to 2 years from first dose of T3011', 'description': 'Measurement of ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1 (test Nabs when ADAs are positive).'}, {'measure': 'Evaluate the preliminary clinical response of single agent IV T3011', 'timeFrame': 'Up to 2 years from first dose of T3011', 'description': 'ORR PFS and OS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Herpes virus', 'Advanced solid tumor', 'Dose escalation', 'T3011', 'Oncolytic virus'], 'conditions': ['Advanced Solid Tumor', 'Lung Cancer', 'Liver Cancer', 'Lymphoma', 'Mesothelioma of Pleura']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label study conducted in 3 phases:\n\nDose escalation stage: The stage contain 4 cohorts, each cohort divided into 2 groups （group A, single dose and Group B, multiple dose）.Dose escalation will use a 3+3 design to evaluate escalating doses of T3011.Cohorts of three subjects will be enrolled at each T3011 dose level with expansion to six subjects, if necessary, to assess toxicity. Total enrollment will depend on the toxicities observed, with approximately 4-24 evaluable subjects enrolled in dose escalation stage.\n\nDose extension stage: The SMC will evaluate the available safety and preliminary efficacy data and initiate dose-expansion studies for the appropriate indications Phase IIa: To explore the safety of intravenous administration and expand the study in other indications. the stage will be carried out gradually based on the data obtained from the phase I study.', 'detailedDescription': 'This is a multicenter, open-label study conducted in 3 phases:\n\nDose escalation stage: The stage contains 4 cohorts, divided into cohort 1 (1x106PFU/ dose), cohort 2 (1x107PFU/ dose), cohort 3 (1x108PFU/ dose) and cohort 4 (3x108PFU/ dose). Each cohort divided into 2 groups （group A, single dose and Group B, multiple dose）.Dose escalation will use a 3+3 design to evaluate escalating doses of T3011. At any dose level, if no DLT occurs among the first 3 subjects, then escalation to the next dose level may proceed, with the approval of the SMC. If 1 DLT occurs in the first 1 to 3 subjects, the dose level will expand to a maximum of 6 subjects. If no DLT occurs among the additional subjects, then escalation to the next dose level may proceed, with the approval of the SMC. If 2 or more DLTs occur within a cohort, then that dose level will be above the maximum tolerated dose (MTD) (the highest dose where no more than 1 of 6 subjects has experienced a DLT), and new subjects will be enrolled at the previous lower (tolerated) dose level until that cohort has 6 subjects. This lower dose level will be considered the MTD if ≤ 1 in 6 subjects has a DLT. At the end of dose escalation, the SMC will recommend a dose (the recommended phase 2 dose \\[RP2D\\]) of T3011 to be used in phase 2a expansion study based upon MTD identification, cumulative safety, pharmacokinetic (PK), efficacy, and pharmacodynamic data. Total enrollment will depend on the toxicities observed, with approximately 4-24 evaluable subjects enrolled in dose escalation stage.\n\nIn group A, participant will receive a single dose and the DLT evaluation period is 14 days.\n\nIn group B, Participants will receive administration at D1/D4/D8 of every cycle. The DLT evaluation period will be the first 21-day Cycle in group B. Tumor evaluation was performed every two cycles. The maximum treatment period should not exceed 4 cycles. Group B of cohort X was enrolled only after the DLT assessed for group A of cohort X and SMC approval to proceed to the next cohort assessment.\n\nDose extension stage: The SMC will evaluate the available safety and preliminary efficacy data and initiate dose-expansion studies for the appropriate indications Phase IIa: To explore the safety of intravenous administration and expand the study in other indications. the stage will be carried out gradually based on the data obtained from the phase I study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Locally recurrent or metastatic solid tumors, There is currently no effective treatment (including treatment intolerance).\n\n 2\\. Age 18 years or older. 3. At least one target lesion per RECIST version 1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1. 5. Life expectancy ≥ 12 weeks. 6. Women of childbearing potential must have a negative serum pregnancy test at Screening within 7 days of dosing with T3011.\n\n 7\\. Understand and sign ICF voluntarily,capable of understanding and complying with protocol requirements.\n\nExclusion Criteria:\n\n* 1\\. Pregnant or lactating or plan to pregnant or give birth during the trial. 2. Splenectomy, previous allogenic organ transplant. 3. Prior treatment with another gene therapy（except T3011）. 4. Requires continued concurrent systemic therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir). Topical use of drugs against HSV are allowed.\n\n 5\\. History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody or their excipients.\n\n 6\\. Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.'}, 'identificationModule': {'nctId': 'NCT05598268', 'briefTitle': 'A Study of T3011 Administered Via Intravenously in Patients With Advanced Solid Tumors.', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmVira Pharma Co. Ltd'}, 'officialTitle': 'A Phase I/IIa Study to Assess the Safety, Tolerability, Biodistribution and Pharmacodynamic of T3011 Herpes Virus Administered Via Intravenously in Patients With Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'MVR-T3011-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T3011 Herpes Virus Injection', 'interventionNames': ['Biological: T3011']}], 'interventions': [{'name': 'T3011', 'type': 'BIOLOGICAL', 'description': 'T3011 will be administered through IV drip', 'armGroupLabels': ['T3011 Herpes Virus Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233099', 'city': 'Bengbu', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Junbin, Professor', 'role': 'CONTACT', 'email': 'clinicaltrials@immviragroup.com', 'phone': '055-3086120'}], 'facility': 'The First Affiliated Hospital of Bengbu Medicial College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '510280', 'city': 'Guanzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Jian, Professor', 'role': 'CONTACT', 'email': 'clinicaltrials@immviragroup.com', 'phone': '020-61643888'}], 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}, {'zip': '450052', 'city': 'Luoyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Zhiye, Professor', 'role': 'CONTACT', 'email': 'clinicaltrials@immviragroup.com', 'phone': '0379-69823015'}], 'facility': 'the First Affiliated Hospital of Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Luo Suxia, M.D.', 'role': 'CONTACT', 'email': 'clinicaltrials@immviragroup.com', 'phone': '400-0371818'}], 'facility': 'Henan Cancer Hosptial', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '610044', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Shuang, professor', 'role': 'CONTACT', 'email': 'clinicaltrials@immviragroup.com', 'phone': '028-85422114'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '101149', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hu Ying, M.D.', 'role': 'CONTACT', 'email': 'clinicaltrials@immviragroup.com', 'phone': '010-89509000'}], 'facility': 'Beijing Chest Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200030', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Shun, Professor', 'role': 'CONTACT', 'email': 'clinicaltrials@immviragroup.com', 'phone': '86-021-22200000', 'phoneExt': '12345'}], 'facility': 'Shanghai Chest Hosptial', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'ImmVira Pharma Co. LTD', 'role': 'CONTACT', 'email': 'clinicaltrials@immviragroup.com', 'phone': '781-718-5121'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmVira Pharma Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}