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NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

ConditionLocally Advanced Rectal Cancer (LARC)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • NG-350A IV administration

    Drug

    a tumour-selective anti-CD40-expressing adenoviral vector

  • Capecitabine oral administration

    Drug

    chemotherapy

  • Radiotherapy

    Radiation

    long-course intensity-modulated radiotherapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: NG-350A plus CRT during a 12-week active study treatment periodExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients achieving a response (ncCR / cCR)

Time frame
12 weeks after initiating NG-350A in combination with chemoradiotherapy (CRT)

Secondary outcomes

1

Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Time frame
1-3 years
2

Clinical response (CR) outcome

Time frame
12, 18, and 36 weeks after initiating NG-350A plus chemoradiotherapy (CRT)
3

MRI-based tumor regression grade (mrTRG)

Time frame
12, 18, and 36 weeks after initiating NG-350A plus chemoradiotherapy (CRT)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akamis Bio

Lead sponsor

Source ClinicalTrials.gov
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