RecruitingPhase 1NCT06459869

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)

Sponsor

Akamis Bio

Enrollment

30 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Rectal Cancer (LARC)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Capecitabine oral administration, a drug called NG-350A IV administration, and others for people with locally advanced rectal cancer (larc). The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNG-350A IV administration

a tumour-selective anti-CD40-expressing adenoviral vector

DRUGCapecitabine oral administration

chemotherapy

RADIATIONRadiotherapy

long-course intensity-modulated radiotherapy

Locations(7)

University of Southern California

Los Angeles, California, United States

AdventHealth Orlando

Orlando, Florida, United States

Washington University School of Medicine

St Louis, Missouri, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University College London NHS FT

London, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06459869

Related Trials

Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer

NCT073930481 location

SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer

NCT068640131 location

A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer

NCT073479511 location

Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer

NCT072692492 locations

Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.

NCT069403882 locations