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)

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Summary

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Selected Inclusion Criteria: * Histologically confirmed adenocarcinoma of the rectum. * 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. * Confirmed microsatellite stable (MSS)/proficient mismatch repair (pMMR) status. * Provide written informed consent to participate. * ECOG Performa…

Interventions

Drug
NG-350A IV administration
a tumour-selective anti-CD40-expressing adenoviral vector
Drug
Capecitabine oral administration
chemotherapy
Radiation
Radiotherapy
long-course intensity-modulated radiotherapy

Locations (6)

AdventHealth Orlando
Orlando, Florida
Washington University School of Medicine
St Louis, Missouri
Ohio State University Comprehensive Cancer Center
Columbus, Ohio
The University of Texas MD Anderson Cancer Center
Houston, Texas
University College London NHS FT
London
The Royal Marsden NHS Foundation Trust
Sutton