Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02045602
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-23', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability by means of Adverse Events (AEs) and laboratory data', 'timeFrame': 'At least 6 months'}, {'measure': 'Recommended Phase 2 Dose (RP2D) by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities', 'timeFrame': 'At least 6 months'}], 'secondaryOutcomes': [{'measure': 'Presence of VCN-01 in tumor', 'timeFrame': 'Day 8-10', 'description': 'Determination of VCN-01 by analyzing viral genome copies in tumor biopsy'}, {'measure': 'Viral Pharmacokinetics', 'timeFrame': 'Up to 48 h', 'description': 'Determination of VCN-01 half-life by analyzing viral genome copies in blood'}, {'measure': 'Viral Shedding', 'timeFrame': 'Up to day 28', 'description': 'And at least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)'}, {'measure': 'Neutralizing antibodies anti-VCN-01', 'timeFrame': '30 days after end of treatment phase', 'description': 'At least up to 6 months follow-up in patients at the MTD'}, {'measure': 'Preliminary anti-tumor activity by Overall Response Rate (ORR)', 'timeFrame': 'CT or MRI scans every 8 weeks until disease progression'}, {'measure': 'Preliminary anti-tumor activity by Progression Free Survival (PFS)', 'timeFrame': 'CT or MRI scans every 8 weeks until disease progression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Solid Tumors', 'Gemcitabine', 'Oncolytic virus', 'Metastatic', 'Pancreatic cancer'], 'conditions': ['Locally Advanced Solid Tumors', 'Metastatic Solid Tumors', 'Pancreatic Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '35338084', 'type': 'DERIVED', 'citation': 'Garcia-Carbonero R, Bazan-Peregrino M, Gil-Martin M, Alvarez R, Macarulla T, Riesco-Martinez MC, Verdaguer H, Guillen-Ponce C, Farrera-Sal M, Moreno R, Mato-Berciano A, Maliandi MV, Torres-Manjon S, Costa M, Del Pozo N, Martinez de Villarreal J, Real FX, Vidal N, Capella G, Alemany R, Blasi E, Blasco C, Cascallo M, Salazar R. Phase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors. J Immunother Cancer. 2022 Mar;10(3):e003255. doi: 10.1136/jitc-2021-003255.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.', 'detailedDescription': 'The study consists of three parts:\n\n* Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone\n* In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine.\n* In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/Female patients aged 18 years or over\n* Patients must provide written informed consent\n* Part I: Patients with histologically confirmed, locally advanced or metastatic solid tumors. Part II and Part III: Patients with histologically confirmed, pancreatic adenocarcinoma for which the established therapy is Abraxane®/Gemcitabine (clinical standard of care)\n* Life expectancy above 3 months\n* Patients willing to comply with treatment follow-up\n* ECOG Performance status 0 or 1\n* Adequate baseline organ function (hematologic, liver, renal and nutritional)\n* Use a reliable method of contraception in fertile men and women\n\nExclusion Criteria:\n\n* Active infection or other serious illness or autoimmune disease\n* Treatment with live attenuated vaccines in the last three weeks\n* Known chronic liver disease (liver cirrhosis, chronic hepatitis)\n* Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion\n* Viral syndrome diagnosed during the two weeks before inclusion\n* Chronic immunosuppressive therapy\n* Concurrent malignant hematologic or solid disease\n* Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.\n* Patients receiving full-dose anticoagulant / antiplatelet therapy\n* Adequate levels of neutralizing antibodies against adenovirus\n* Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency'}, 'identificationModule': {'nctId': 'NCT02045602', 'briefTitle': 'Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theriva Biologics SL'}, 'officialTitle': 'A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'P-VCNA-001'}, 'secondaryIdInfos': [{'id': '2012-005555-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I: Dose Escalation, Single Agent', 'description': 'Single intravenous injection of VCN-01 oncolytic adenovirus', 'interventionNames': ['Genetic: VCN-01']}, {'type': 'EXPERIMENTAL', 'label': 'Part II: Dose Escalation, Combination', 'description': 'Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine', 'interventionNames': ['Genetic: VCN-01', 'Drug: Gemcitabine', 'Drug: Abraxane®']}, {'type': 'EXPERIMENTAL', 'label': 'Part III: Dose Escalation, Combination, "delayed" schedule', 'description': 'Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine', 'interventionNames': ['Genetic: VCN-01', 'Drug: Gemcitabine', 'Drug: Abraxane®']}], 'interventions': [{'name': 'VCN-01', 'type': 'GENETIC', 'description': 'Genetically modified human adenovirus encoding human PH20 hyaluronidase', 'armGroupLabels': ['Part I: Dose Escalation, Single Agent', 'Part II: Dose Escalation, Combination', 'Part III: Dose Escalation, Combination, "delayed" schedule']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': '1000 mg/m2 intravenous administration', 'armGroupLabels': ['Part II: Dose Escalation, Combination', 'Part III: Dose Escalation, Combination, "delayed" schedule']}, {'name': 'Abraxane®', 'type': 'DRUG', 'description': '125 mg/m2 intravenous administration', 'armGroupLabels': ['Part II: Dose Escalation, Combination', 'Part III: Dose Escalation, Combination, "delayed" schedule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': "Institut Català d'Oncologia", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '25080', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Centro Integral Oncológico Clara Campal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theriva Biologics SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}