RecruitingPhase IInterventional

An early safety study testing a drug combination given before possible surgery for people with pancreatic cancer that can’t be easily removed yet or hasn’t spread far

This study is for people with a type of pancreatic cancer that hasn't spread widely but is difficult to remove with surgery right away. Researchers want to see if adding three new medicines – nogapendekin alfa inbakicept (NAI), sotevtamab, and zabadinostat – to standard chemotherapy can help shrink the cancer before an operation. The main goal of this early-stage study is to check the safety of this new combination and understand its side effects. They will also look for early signs that the treatment is working. Participants will receive these medicines before surgery, and some may continue with one of the new drugs afterwards. It's hoped this could make surgery more successful and help control the cancer.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Serum Life Science Europe GmbH

Enrolment target

Start

01 Jan 2026

Estimated completion

01 Apr 2027

Borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC)

What is this study about?

This study is looking for better ways to treat a specific type of pancreatic cancer. This is cancer that hasn't spread far to other parts of the body, but it's in a difficult position, making it hard for surgeons to remove it straight away. The main idea behind this research is to see if a combination of new drugs, given before surgery, can help shrink the tumour or stop it from growing. This might make the surgery easier and more effective in the long run.

The drugs being tested include standard chemotherapy, which is already used for pancreatic cancer, plus three new experimental medicines: nogapendekin alfa inbakicept (NAI), sotevtamab, and zabadinostat. These new medicines are designed to help your body's own immune system fight the cancer. Because this is an early-stage study, the most important thing researchers want to find out is how safe this particular combination of five medicines is and what side effects people experience. They will also be carefully watching for any early clues that the treatment is helping to control the cancer.

If the treatment before surgery works well and makes the tumour more manageable, people in the study might then have an operation to remove the cancer. After surgery, some might continue taking one of the new medicines (NAI) to help keep the cancer from coming back. By gathering this information, the researchers hope to learn more about how to treat this type of pancreatic cancer, potentially benefiting you and others in the future.

Key takeaways

This study tests a new combination of five drugs for pancreatic cancer.
It's for cancer that hasn't spread widely but is hard to remove with surgery.
The main aim is to check the safety and side effects of the drug combination.
Treatments are given before potential surgery, and some may continue afterwards.
It's an early-stage UK study funded by ImmunityBio, Inc. (USA).
Participation includes regular checks and strict monitoring for safety.

Who may be eligible?

This study is for adults aged 18 or older who have a specific type of pancreatic cancer. This cancer must not have spread to distant parts of the body. It should be either 'borderline resectable' (meaning surgery is possible but tricky) or 'locally advanced' (meaning surgery isn't possible right now).

To join, you must generally be well enough to take part in a study like this, as assessed by a special score (ECOG 0 or 1). Your doctors will also need to be able to measure the cancer on scans. Importantly, you cannot have had any previous treatment for your pancreatic cancer. If you are female and could become pregnant, or a non-sterile male, you must agree to use reliable birth control during and for several months after the study.

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.

Are you 18 years old or older?
Do you have pancreatic cancer that hasn't spread far but is difficult for surgery or locally advanced?
Have you not had any other cancer treatment for your pancreatic cancer before?
Are you generally well enough to take part in such a study (your doctor will check this)?
Are you willing to use reliable birth control if you are female and could become pregnant, or a non-sterile male?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive standard chemotherapy medicines (gemcitabine and nab-paclitaxel) along with three new study medicines (nogapendekin alfa inbakicept, sotevtamab, and zabadinostat). These will be given over several treatment blocks, typically lasting about 2 to 6 months in total. These treatments are given before any surgery, with the goal of shrinking or controlling the cancer.

Throughout the study, you'll have regular visits where doctors will perform scans to check the size of your tumour. They'll also take blood and tissue samples to see how the treatment is working inside your body. If the pre-surgery treatment is successful and your cancer can then be removed, you will have surgery. After surgery, you might continue with one of the study medicines (NAI) every two weeks, unless the cancer worsens or side effects become too much. The total duration of your involvement will depend on how your cancer responds.

Potential risks and benefits

While there's no guarantee, taking part could help researchers learn more about your cancer and the study treatments, potentially benefiting you and others in the future. However, there are possible risks. You might experience side effects from the treatments, including common ones like fever, chills, tiredness, nausea, vomiting, diarrhoea, and low blood cell counts. The new drugs can also cause specific reactions, such as flu-like symptoms, skin rashes, or pain where an injection is given. Since this study uses five different drugs together, there's a chance of combined side effects, and some may be unexpected as this particular combination hasn't been fully studied in pancreatic cancer yet. There are also risks from procedures like blood tests (pain, bruising), CT scans (small amount of radiation), and surgery (a major operation with risks like bleeding or infection). The study team will closely monitor you for side effects, and you can withdraw from the study at any time if you wish.

Locations (2)

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

NIHR/Wellcome Trust Clinical Research Facility
City only
Birmingham, England
Chang Soon Shiong Institute of Medicine
City only
El Segundo, United States of America

Common questions

What does 'early safety study' mean?

It means this is a very first study where the main goal is to check if the new drug combination is safe and what side effects it causes, rather than primarily looking at how well it treats the cancer at this stage.

What is 'neoadjuvant treatment'?

This is treatment, like chemotherapy or these new drugs, given before surgery. The aim is to shrink the cancer or stop it from growing, making surgery more successful or even possible.

Are the study drugs approved for use?

No, the three new study medicines (nogapendekin alfa inbakicept, sotevtamab, zabadinostat) are experimental and not yet approved for general use. They are still being tested.

How long will I be on the treatment before surgery?

You might get between 2 and 6 cycles (blocks) of treatment, which usually takes about 2 to 6 months in total. This depends on how your cancer responds and how you are feeling.

What are the common side effects?

Common expected side effects include fever, chills, flu-like symptoms, tiredness, itching, nausea, vomiting, diarrhoea, and low blood cell counts. The study team will monitor you closely.

How to find out more

Phillip Trieu

Phillip.trieu@immunitybio.com (856) 739-5609 Official trial record

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