[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Akamis Bio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100551421",false,"NCT06459869","NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer","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)","FORTRESS","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\u002Fchemoradiation.\n* Confirmed microsatellite stable (MSS)\u002Fproficient 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\u002Fhematological 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\u002Fchemoradiation.\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\u002Fcoagulopathy.\n\nURL:\n\nhttps:\u002F\u002Fwww.FortressStudy.org","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.",[26],"Locally Advanced Rectal Cancer (LARC)",[28,29],"Treatment naive","Oligometastatic","RECRUITING","2026-06-10",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":34},"2025-04-07",{"date":38,"type":20},"2028-12-30",{"name":40,"class":41},"Akamis Bio","INDUSTRY",7,""]