NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

Conditions

• Locally Advanced Rectal Cancer (LARC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Apr 7, 2025

Status verified

Aug 2025

Primary completion

Nov 30, 2026

Completion

Nov 30, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: NG-350A plus CRT during a 12-week active study treatment period

Primary Outcome Measure

Proportion of patients achieving a response (ncCR / cCR) [ Time Frame: 12 weeks after initiating NG-350A in combination with chemoradiotherapy (CRT) ]

Central Contacts

• Vice President Head of Clinical Operations
  +1 (484) 362-8918
  [email protected]
• https://www.FortressStudy.org
  [email protected]

Locations (4)

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