Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT07192432
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-09-17
Is Possible Gene Therapy:
True
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2033-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2033-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in VNX-202 gene product levels', 'timeFrame': 'Change from baseline to year 5 post dosing'}, {'measure': 'Change in VNX-202 vector shedding', 'timeFrame': 'Change from baseline to year 5 post dosing'}], 'primaryOutcomes': [{'measure': 'Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)', 'timeFrame': 'Change from Baseline to Year 5 post dosing'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in T cell subsets and clonality', 'timeFrame': 'Change from baseline to year 5 post dosing'}, {'measure': 'Change from baseline in ctDNA', 'timeFrame': 'Change from baseline to year 5 post dosing'}, {'measure': 'Change from baseline in progression free survival', 'timeFrame': 'Change from baseline to year 5 post dosing'}, {'measure': 'Change from baseline in overall survival', 'timeFrame': 'Change from baseline to year 5 post dosing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2+ breast cancer', 'HER2+ gastric cancer', 'Other HER+ cancer', 'HER2-low cancer'], 'conditions': ['HER2 Expressing Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.', 'detailedDescription': 'VNX-202 is an investigational adeno-associated virus (AAV) gene therapy developed to express a secreted anti-HER2/anti-CD3 scFv diabody (termed GP202). GP202 binds to human epidermal growth factor receptor 2 (HER2) on the surface of cancer cells and to cluster of differentiation (CD)3 on the surface of T cells, inducing the T cells to kill the HER2-positive cancer cells.\n\nFollowing a single intravenous (IV) infusion, the vector induces the liver to continuously secrete GP202 into the bloodstream, resulting in long-term, consistent serum levels of GP202. Compared with conventionally delivered protein therapies, this gene therapy approach obviates the requirement for episodic dosing and avoids a possible reduction or loss of efficacy associated with trough levels of the protein between treatment cycles.\n\nIn this 2-part study, dose-finding data from Part 1 of the study (n=\\~12 patients) will be used determine the dose for Part 2 in patients. Part 1 is a dose-finding PK study in adults ≥18 years old with previously treated metastatic HER2 solid tumors designed to determine the minimal dose that achieves target PK serum levels of GP202 at steady state (8-week timepoint) without dose-limited toxicities, defined as the recommended Part 2 dose (RP2D). Participants must have histologically or cytologically confirmed HER2 positive solid tumor cancers that has progressed during or following previous anti-cancer treatment. Part 2 (n=\\~15) will be opened following data safety monitoring board review of Part 1 data and is designed to determine the safety and pharmacokinetics (PK) of VNX-202 at the RP2D in a broader array of subjects. Part 2 will comprise of participants with early stage HER2-positive tumors who are at risk of disease relapse and/or metastasis despite having received prior systemic and/or local treatment. Each cohort will comprise ≥5 participants (Cohort A: breast cancer; Cohort B: gastric cancer; Cohort C: all otherHER2-positive tumor types). Patients will be followed for safety and efficacy up to 5 years post VNX-202 dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥18 years of age\n* Histologically or cytologically confirmed diagnosis of HER-2 positive solid tumor as defined in the protocol\n* Part 1: presence of advanced or metastatic disease that has progressed during or following previous treatment\n* Part 2: Early stage HER-2 positive cancers with high risk for relapse following completion of SOC or after neoadjuvant systemic treatment\n* AAV specified capsid total antibody ≤1:400\n* ECOG performance status of 0 or 1\n* Life expectancy ≥3 months\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* Known active CNS or leptomeningeal disease\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* History of other malignancy within 5 years prior to screening as defined in protocol\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity Concurrent anti-cancer treatment in another investigational trial'}, 'identificationModule': {'nctId': 'NCT07192432', 'acronym': 'SENTRY-HER2', 'briefTitle': 'Gene Therapy for HER-Positive Cancer (SENTRY-HER2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vironexis Biotherapeutics Inc.'}, 'officialTitle': 'A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer', 'orgStudyIdInfo': {'id': 'VNX-202-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1/Group 2/Group 3/Group 4', 'interventionNames': ['Genetic: Dose Level 1, VNX-202', 'Genetic: Dose Level 2, VNX-202', 'Genetic: Dose Level 3, VNX-202', 'Genetic: Dose Level 4, VNX-202']}], 'interventions': [{'name': 'Dose Level 1, VNX-202', 'type': 'GENETIC', 'description': 'Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion', 'armGroupLabels': ['Group 1/Group 2/Group 3/Group 4']}, {'name': 'Dose Level 2, VNX-202', 'type': 'GENETIC', 'description': 'Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion', 'armGroupLabels': ['Group 1/Group 2/Group 3/Group 4']}, {'name': 'Dose Level 3, VNX-202', 'type': 'GENETIC', 'description': 'Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion', 'armGroupLabels': ['Group 1/Group 2/Group 3/Group 4']}, {'name': 'Dose Level 4, VNX-202', 'type': 'GENETIC', 'description': 'Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion', 'armGroupLabels': ['Group 1/Group 2/Group 3/Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia Etchart', 'role': 'CONTACT', 'email': 'julia.etchart@sarahcannon.com', 'phone': '805-701-0185'}], 'facility': 'SCRI Denver DDU at HealthOne', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SCRI Referrals', 'role': 'CONTACT', 'email': 'SCRI.DDUreferrals@scri.com', 'phone': '615-329-7274'}], 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Allen Reha', 'role': 'CONTACT', 'email': 'allen.reha@vironexis.com', 'phone': '908-938-6019'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vironexis Biotherapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}