RecruitingPHASE1INTERVENTIONAL

NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

This research, called the FORTRESS trial, is looking at a new treatment for locally advanced bowel cancer in the back passage (rectum). Participants will receive a drug called NG-350A, given directly into a vein, in addition to their usual chemotherapy (capecitabine tablets) and radiotherapy. The main goal is to understand how safe this new drug combination is and whether it helps treat the cancer. It's for adults whose cancer has not spread far but has certain risk factors for returning. This is an early-stage study (Phase 1), meaning it's one of the first times this combination is being tested in people.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Akamis Bio

Enrolment target

Start

07 Apr 2025

Estimated completion

30 Nov 2028

Locally Advanced Rectal Cancer (LARC)

What is this study about?

This study is investigating a new treatment approach for bowel cancer located in the rectum, which is the final part of the large intestine. Doctors refer to this as 'locally advanced rectal cancer.' This means the cancer has grown into the nearby tissues but hasn't spread widely to other parts of the body. The standard treatment often involves chemotherapy and radiotherapy, sometimes followed by surgery. This combination aims to shrink the tumour before surgery, making the operation easier and more successful.

The trial is introducing a new drug called NG-350A. This drug will be given into a vein (intravenously) alongside the usual chemotherapy tablets (Capecitabine) and radiotherapy. The researchers want to see if adding NG-350A makes the overall treatment more effective and what the side effects might be. By offering this extra treatment, they hope to improve outcomes for patients with this type of cancer, especially if their cancer has particular features that might make it more likely to come back.

This is an early-stage study (a Phase 1 trial), which means it's primarily focused on safety. Researchers will be carefully monitoring participants to understand how their bodies react to NG-350A when combined with standard treatments. They will also be looking for early signs of how well the treatment works against the cancer. All findings from trials like this help doctors learn how to best treat cancer in the future.

Key takeaways

This study is for adults with locally advanced rectal cancer.
It combines a new drug (NG-350A) with standard chemotherapy and radiotherapy.
It's a Phase 1 study, mainly focused on safety and side effects.
Participants will have regular hospital visits for treatment and monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult patients who have been diagnosed with bowel cancer in the rectum that is 'locally advanced.' This means the cancer has grown into nearby tissues but has not spread significantly to other parts of the body. Your care team should have discussed and agreed that you are suitable for treatment with chemotherapy and radiotherapy.

You should generally be in good health, able to carry out most daily activities, and not be pregnant or breastfeeding. If you are sexually active, you'll need to agree to use effective contraception if needed. The medical team will also check that your major organs like lungs, kidneys, liver, and blood are working well.

Certain situations would mean you cannot join the study, such as if your rectal cancer has returned after previous treatment or if it has spread widely to other organs. You also wouldn't be eligible if you've had certain other cancers recently, have an active autoimmune disease that needs strong medication, or have had your spleen removed.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have locally advanced rectal cancer?
Am I generally well and able to perform most daily activities?
Am I currently pregnant or breastfeeding?
Have my care team agreed I'm suitable for chemotherapy and radiotherapy?
Have I had other cancers recently, or do I have an active autoimmune disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the investigational drug NG-350A through an IV drip, alongside your prescribed Capecitabine tablets (oral chemotherapy) and radiotherapy, as planned by your medical team. You will have regular appointments at the hospital for treatments, check-ups, blood tests, and scans to monitor your health and how the treatment is working against your cancer. These visits will be more frequent than standard care, especially during the treatment phase.

The medical team will carefully explain the schedule of drug administration, chemotherapy and radiotherapy, and all required tests. You will be asked to complete questionnaires and regularly discuss any side effects or changes in your health. The total duration of your participation will depend on the treatment plan and follow-up schedule, which will be clearly outlined by the study team before you enroll. This could involve several months of active treatment followed by a period of monitoring.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new, potentially more effective treatment before it's widely available. While there's no guarantee the new drug will benefit you personally, it could help improve future cancer treatments. However, there are potential risks, as NG-350A is an investigational drug, and its full range of side effects, especially in combination with standard treatments, is not yet fully known. The study team will closely monitor you and manage any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

AdventHealth Orlando
Verified postcode
Orlando, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting
Ohio State University Comprehensive Cancer Center
Verified postcode
Columbus, United States· Recruiting
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
University College London NHS FT
Verified postcode
London, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is 'locally advanced rectal cancer'?

This means your bowel cancer in the rectum has grown into nearby tissues but hasn't spread widely to other parts of your body yet.

What is NG-350A?

NG-350A is a new drug being tested in this trial. It's given through a drip into your vein (IV administration).

What does a 'Phase 1' trial mean?

A Phase 1 trial is an early stage of clinical research. Its main purpose is to find out if a new treatment is safe and what dose can be given, rather than how well it works.

Will I still receive my normal chemotherapy and radiotherapy?

Yes, if you join this study, you will receive the new drug NG-350A in addition to your standard chemotherapy (Capecitabine) and radiotherapy.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect your future medical care.

How to find out more

Vice President Head of Clinical Operations

robert.maietta@akamisbio.com +1 (484) 362-8918 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.