Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT06459869
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving a clinical complete response (cCR)', 'timeFrame': '12 weeks after initiating NG-350A in combination with chemoradiotherapy (CRT)'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0', 'timeFrame': '1-3 years'}, {'measure': 'Clinical response (CR) outcome', 'timeFrame': '12, 18, and 36 weeks after initiating NG-350A plus chemoradiotherapy (CRT)'}, {'measure': 'MRI-based tumor regression grade (mrTRG)', 'timeFrame': '12, 18, and 36 weeks after initiating NG-350A plus chemoradiotherapy (CRT)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment naive', 'Oligometastatic'], 'conditions': ['Locally Advanced Rectal Cancer (LARC)']}, 'referencesModule': {'references': [{'pmid': '39414325', 'type': 'DERIVED', 'citation': 'Naing A, Khalil D, Rosen O, Camidge DR, Lillie T, Ji RR, Stacey A, Thomas M, Rosen L. First-in-human clinical outcomes with NG-350A, an anti-CD40 expressing tumor-selective vector designed to remodel immunosuppressive tumor microenvironments. J Immunother Cancer. 2024 Oct 15;12(10):e010016. doi: 10.1136/jitc-2024-010016.'}]}, 'descriptionModule': {'briefSummary': 'The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Selected Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the rectum.\n* Locally advanced disease (clinical stage II-III based on pelvic MRI) selected by a multidisciplinary team for treatment with neoadjuvant CRT (which may be followed by CNCT to comprise planned TNT). Patients with oligometastatic disease are permitted provided that the site-specific multidisciplinary team deems them suitable for radical treatment/chemoradiation.\n* Confirmed microsatellite stable (MSS)/proficient mismatch repair (pMMR) status.\n* Provide written informed consent to participate.\n* ECOG Performance Status 0 or 1.\n* Must not be pregnant or breastfeeding.\n* Patients who are sexually active (with either sex) must agree to comply with contraceptive requirements.\n* Adequate lung reserve, renal function, hepatic function, and bone marrow/hematological function assessed ≤ 10 days prior to first dose.\n\nSelected Exclusion Criteria:\n\n* Recurrent rectal cancer.\n* Distant metastatic disease not amenable to radical treatment/chemoradiation.\n* Other prior malignancy active within the previous 3 years, except for local or organ confined early-stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the trial, including response rate and safety.\n* Splenectomy (patients with prior partial resection remain eligible if the Investigator considers splenic function to not be significantly compromised).\n* Active autoimmune disease that has required systemic therapy in the past 2 years, immunocompromised status in the opinion of the Investigator, or current treatment with systemic immunosuppressive therapy (daily prednisone equivalent for chronic system replacement not to exceed 10mg per day).\n* Infectious or inflammatory bowel disease in the 3 months before the first dose of study treatment.\n* Any clinically significant cardiovascular, peripheral vascular, cerebrovascular, or thromboembolic event in the last 1 month before the first dose of study treatment.\n* Major surgery in the 14 days before the first dose of study treatment or any surgical wounds that are not fully healed and free of infection or dehiscence.\n* Any prior surgery for rectal cancer or pelvic radiotherapy.\n* Any other anti-cancer or experimental therapy within the previous 12 months or that is planned during the active study treatment period.\n* Treatment with any other enadenotucirev-based virus (parent virus or transgene-modified variants), or anti-CD40 antibody at any time.\n* History of prior Grade 3-4 acute kidney injury or other clinically significant renal impairment.\n* Any ongoing Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 coagulation abnormality/coagulopathy.'}, 'identificationModule': {'nctId': 'NCT06459869', 'acronym': 'FORTRESS', 'briefTitle': 'NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akamis Bio'}, 'officialTitle': 'A Multicentre, Open-label, Non-randomized, Phase 1b Trial of NG-350A, a Tumour-selective Anti-CD40-expressing Adenoviral Vector, in Combination With Chemoradiotherapy in Locally Advanced Rectal Cancer (FORTRESS)', 'orgStudyIdInfo': {'id': 'NG-350A-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NG-350A plus CRT during a 12-week active study treatment period', 'interventionNames': ['Drug: NG-350A IV administration', 'Drug: Capecitabine oral administration', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'NG-350A IV administration', 'type': 'DRUG', 'description': 'a tumour-selective anti-CD40-expressing adenoviral vector', 'armGroupLabels': ['NG-350A plus CRT during a 12-week active study treatment period']}, {'name': 'Capecitabine oral administration', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['NG-350A plus CRT during a 12-week active study treatment period']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'long-course intensity-modulated radiotherapy', 'armGroupLabels': ['NG-350A plus CRT during a 12-week active study treatment period']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohamedtaki Tejani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Miller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sonal Noticewala', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Maria Hawkins', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University College London NHS FT', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Sutton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sheela Rao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'centralContacts': [{'name': 'Vice President Head of Clinical Operations', 'role': 'CONTACT', 'email': 'robert.maietta@akamisbio.com', 'phone': '+1 (484) 362-8918'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akamis Bio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}