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RecruitingPhase I and Phase II (Integrated)- OtherInterventional

An open-label phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma

Pancreatic cancer can be difficult to treat once it has spread to other areas of the body, which doctors call metastatic cancer. This clinical trial is testing a new drug called mitazalimab given alongside standard chemotherapy medicines. Mitazalimab is an immunotherapy. It is designed to help the body's natural immune system spot and attack cancer cells. Chemotherapy works alongside it to slow or stop cancer growth. The main goals of this study are to check that the combined treatment is safe, find the most effective dose, and see how well it shrinks or stabilises tumours. Adults aged 18 and over with this specific type of pancreatic cancer may be able to take part. Taking part involves hospital visits for drug drips, regular scans, and blood tests to monitor your health and response to treatment.

At a glance

Status
Recruiting
Phase
Phase I and Phase II (Integrated)- Other
Sponsor
Alligator Bioscience AB
Enrolment target
94
Start
04 Oct 2024

What is this study about?

The pancreas is an organ that sits behind the stomach, helping to digest food and balance blood sugar levels. Pancreatic ductal adenocarcinoma is the most common form of pancreatic cancer. When the cancer spreads beyond the pancreas to other organs, it is known as metastatic cancer. At this stage, standard treatments aim to manage symptoms, slow down tumour growth, and help people live longer.

This trial is investigating whether adding an experimental drug called mitazalimab to standard chemotherapy works better than chemotherapy alone. Mitazalimab is an immunotherapy drug. Unlike standard chemotherapy, which attacks rapidly dividing cells, immunotherapy works by activating your own immune defence system so it can recognise and fight the cancer.

The trial has two main parts. The first part checks the safety of mitazalimab when given with chemotherapy and finds the best dose to use. The second part looks at how well the combination works to shrink tumours, delay the cancer from progressing, and improve survival times. By taking part, patients help researchers learn whether this new combination could become a helpful future treatment for people facing advanced pancreatic cancer.

Key takeaways

  • Tests a new immunotherapy drug (mitazalimab) combined with standard chemotherapy.
  • Aimed at adults aged 18 and older with metastatic pancreatic cancer.
  • Main goals are to check safety, find the right dose, and see if tumours shrink.
  • Requires regular hospital visits for drug infusions, blood tests, and scans.
  • Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to men and women aged 18 or older who have been diagnosed with metastatic pancreatic ductal adenocarcinoma. This means the cancer began in the ducts of the pancreas and has already spread to other areas of the body.

To join, participants usually need to be well enough to carry out everyday activities, such as looking after themselves and walking around. Doctors will also check that your vital organs, such as your liver, kidneys, and bone marrow, are working well enough to receive treatment safely.

You may not be able to take part if you have certain other serious health issues, severe active infections, or if you have had specific cancer treatments very recently. A hospital trial doctor will review your full medical history and recent test results to see if the trial is right for you.

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.

  1. I am aged 18 or over.
  2. I have been diagnosed with pancreatic ductal adenocarcinoma that has spread (metastatic).
  3. I am well enough to carry out daily self-care and get to hospital visits.
  4. I am willing to receive regular intravenous treatments and attend scan appointments.
  5. My liver and kidneys are working well based on routine blood tests.
Answer every question to see your result.

What does participation involve?

If you take part, you will receive treatment through a drip into a vein at the hospital clinic. This includes mitazalimab along with standard chemotherapy drugs given in regular treatment cycles. You will visit the hospital frequently at first for treatment, physical checks, and blood tests so the team can monitor how you feel and watch for side effects. Every few weeks, you will have imaging scans (such as CT scans) to check if your tumours are shrinking or staying the same. Treatment usually continues for as long as it is helping and side effects remain manageable. Afterwards, the team will continue to check on your health through follow-up visits or phone calls.

Potential risks and benefits

Taking part might help shrink your cancer or keep it under control, but there is no guarantee that this treatment will work for you. The trial will also help doctors learn more about treating pancreatic cancer in the future. However, there are risks of side effects. Chemotherapy commonly causes tiredness, sickness, hair thinning, and a higher risk of infections. The experimental drug can also cause allergic reactions or immune system side effects. Your care team will watch you closely and treat any problems that arise. Joining is entirely your choice, and you can leave the study at any time without it affecting your standard NHS care.

Locations (3)

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

Common questions

What is mitazalimab?

Mitazalimab is an experimental antibody medicine designed to stimulate your immune system so it can better attack cancer cells.

Will I know which medicines I am receiving?

Yes. This is an open-label study, which means both you and your doctor will know that you are receiving mitazalimab with chemotherapy.

Do I have to pay to take part?

No. The trial treatment and all study tests are provided free of charge, and some trials help cover travel expenses to the hospital.

What happens if the treatment does not work?

If your scans show the cancer is growing or if side effects become too difficult, the trial treatment will stop and your doctor will discuss other care options with you.

Can I leave the study if I change my mind?

Yes. You are free to withdraw from the trial at any point, and your regular medical team will continue to support you with standard treatment.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "An open-label phase 1b/2 study assessing the safety and effi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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