Actively Recruiting
NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Led by Akamis Bio · Updated on 2026-02-17
30
Participants Needed
6
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the rectum.
- Locally advanced disease (clinical stage II-III based on pelvic MRI) selected by a multidisciplinary team for neoadjuvant chemoradiotherapy.
- Patients with oligometastatic disease suitable for radical treatment/chemoradiation.
- Confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) status.
- Provide written informed consent.
- ECOG Performance Status 0 or 1.
- Not pregnant or breastfeeding.
- Sexually active patients must agree to contraceptive requirements.
- Adequate lung, kidney, liver, and bone marrow function assessed within 10 days before first dose.
You will not qualify if you...
- Recurrent rectal cancer.
- Distant metastatic disease not suitable for radical treatment/chemoradiation.
- Other active malignancy within last 3 years except certain early-stage cancers definitively treated.
- Splenectomy (except partial resection with adequate splenic function).
- Active autoimmune disease requiring systemic therapy in past 2 years.
- Immunocompromised status or current systemic immunosuppressive therapy exceeding prednisone 10mg/day.
- Infectious or inflammatory bowel disease within 3 months before first dose.
- Significant cardiovascular, peripheral vascular, cerebrovascular, or thromboembolic events within 1 month before first dose.
- Major surgery within 14 days before first dose or unhealed surgical wounds.
- Prior surgery for rectal cancer or pelvic radiotherapy.
- Anti-cancer or experimental therapy within 12 months or planned during study.
- Previous treatment with enadenotucirev-based virus or anti-CD40 antibody.
- History of severe acute kidney injury or significant renal impairment.
- Ongoing CTCAE Grade 2 or higher coagulation abnormalities.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
AdventHealth Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
University College London NHS FT
London, United Kingdom
Actively Recruiting
6
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Actively Recruiting
Research Team
V
Vice President Head of Clinical Operations
CONTACT
H
https://www.FortressStudy.org
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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