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NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

NCT06459869 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Cancer (LARC)

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

Sponsors & Collaborators

  • Akamis Bio

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2026-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06459869 on ClinicalTrials.gov