[{"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:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100551421","phase-1-ng-350a-plus-chemoradiotherapy-for-locally-advanced-rectal-cancer-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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Locally Advanced Rectal Cancer (LARC)",[29,30],"Treatment naive","Oligometastatic","RECRUITING","2026-06-10",{"date":34,"type":35},"2026-06-12","ACTUAL",{"date":37,"type":35},"2025-04-07",{"date":39,"type":21},"2028-12-30",{"name":41,"class":42},"Akamis Bio","INDUSTRY",7,""]