NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkamis Bio
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Recurrent rectal cancer.
Distant metastatic disease not amenable to radical treatment/chemoradiation.
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.
Splenectomy (patients with prior partial resection remain eligible if the Investigator considers splenic function to not be significantly compromised).
Trial design
Treatments tested in this trial
- NG-350A IV administration
- Capecitabine oral administration
- Radiotherapy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov