NG-350A + Chemoradiotherapy for Rectal Cancer

(FORTRESS Trial)

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Akamis Bio

No Placebo Group

Trial Summary

What is the purpose of 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.

Research Team

Eligibility Criteria

This trial is for adults with advanced rectal cancer who are not pregnant or breastfeeding, can perform daily activities (ECOG 0-1), agree to use contraception, and have stable vital organ functions. It's specifically for those with a certain type of genetic status in their cancer cells (MSS/pMMR) and who are chosen for neoadjuvant chemoradiotherapy.

Inclusion Criteria

I have signed a consent form to participate.

I am not pregnant or breastfeeding.

I agree to follow the study's birth control requirements.

Treatment Details

Interventions

• Capecitabine (Chemotherapy)
• NG-350A (Virus Therapy)
• Radiotherapy (Radiation)

Trial Overview The FORTRESS trial tests NG-350A given through IV along with standard chemoradiotherapy, which includes radiation therapy and oral Capecitabine. The goal is to see how well this combination works in treating locally advanced rectal cancer.

Participant Groups

Group I: NG-350A plus CRT during a 12-week active study treatment period Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Akamis Bio

Lead Sponsor

Trials

13

Recruited

820+