NCT06459869

NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Akamis Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-11-30
• Completion: 2028-11-30
• First posted: 2024-06-14
• Last updated: 2026-02-17

Locations

6 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study