All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

Doctors are studying a new medicine called AZD5863 to see if it's safe and effective for adults with advanced stomach, gastro-oesophageal junction, oesophageal, or pancreatic cancer. This medicine is designed to help your immune system find and fight cancer cells. It's a 'Phase 1/2' study, meaning it's still in the early stages of testing. Researchers will give the medicine either into a vein or under the skin. They will carefully check for any side effects and will also look to see if the medicine shrinks the tumours or stops them from growing. This type of research helps us understand if new treatments could be helpful for patients in the future.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
AstraZeneca
Enrolment target
280
Start
11 Jul 2023
Estimated completion
16 Jul 2027

What is this study about?

This study is looking into a new experimental medicine called AZD5863. It's being tested in adults who have stomach, gastro-oesophageal junction, oesophageal, or pancreatic cancer that has spread or is advanced. The main goal is to find out if AZD5863 is safe to use, what dose is best, and if it can help slow down or shrink the cancer.

AZD5863 is a special type of medicine. It's designed to help your body's immune system, which usually fights off infections, to also recognise and attack cancer cells. Think of it like giving your immune cells a special pair of 'glasses' that help them spot the cancer cells specifically. By doing this, doctors hope the medicine can help your own body fight the cancer more effectively.

This is an early-stage study, called a Phase 1/2 trial. This means it's one of the first times this medicine is being given to people. Researchers will be very careful to monitor participants for any side effects. They will also be looking closely to see if the medicine has any positive effects on the cancer. Learning about new medicines like AZD5863 is really important as it helps us discover potential new ways to treat cancer in the future.

Key takeaways

  • This study is testing a brand new medicine for advanced stomach, oesophageal, or pancreatic cancer.
  • The medicine aims to help your own immune system fight the cancer.
  • It's an early-stage study, focusing on safety and finding the best dose.
  • You would receive the active medicine, not a dummy treatment.
  • Your health and safety would be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with stomach, gastro-oesophageal junction, oesophageal, or pancreatic cancer. Your cancer must have spread or be advanced, and you should have already tried at least one other treatment for it that didn't work as well as hoped. Doctors will also check that your cancer cells have a specific marker called CLDN18.2, as the study medicine targets this.

For your safety, there are some reasons why you might not be able to join. For example, if you have certain heart problems, active infections like HIV or hepatitis, or certain autoimmune conditions. You also shouldn't have had specific severe side effects from similar types of treatment in the past.

Doctors will also need to make sure your general health is good enough to take part, checking things like your blood tests and how well your organs are working. They will also need to see that your cancer can be measured accurately to see if the treatment is working.

Quick self-check
  • Are you at least 18 years old?
  • Do you have advanced stomach, gastro-oesophageal junction, oesophageal, or pancreatic cancer?
  • Have you already tried at least one other treatment for your cancer?
  • Are you generally well enough for a study, with no major heart or infection issues?
  • Is your cancer of a type that has the CLDN18.2 marker?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll receive the study medicine, AZD5863. This will either be given into a vein (like a drip) or as an injection under your skin. The study will involve regular visits to the hospital for the medicine, blood tests, and scans to check on your health and whether the medicine is affecting your cancer. The study is divided into two parts: first, a small group will help doctors find the best dose (this might involve a shorter or longer stay in the hospital depending on how you react), and then more people will receive that dose. You would continue treatment as long as it's helping you and you're not experiencing severe side effects. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

While we hope this new medicine might help fight your cancer, it's important to remember it's still experimental, and we don't know for certain if it will work. Potential benefits could include slowing down or shrinking your cancer. However, like all medicines, AZD5863 can have side effects. These will be carefully monitored, and the research team will explain them in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

  • Research Site
    Jacksonville, United States· Recruiting
  • Research Site
    Rochester, United States· Recruiting
  • Research Site
    New York, United States· Withdrawn
  • Research Site
    Beijing, China· Recruiting
  • Research Site
    Beijing, China· Recruiting
  • Research Site
    Shandong, China· Recruiting
  • Research Site
    Toulouse, France· Recruiting
  • Research Site
    Villejuif, France· Recruiting
  • Research Site
    Chūōku, Japan· Recruiting
  • Research Site
    Kashiwa, Japan· Recruiting
  • Research Site
    Kōtoku, Japan· Recruiting
  • Research Site
    Amsterdam, Netherlands· Recruiting

+13 more sites — see the official record for the full list.

Common questions

What is AZD5863?

AZD5863 is a new experimental medicine designed to help your immune system fight certain types of cancer.

What types of cancer is this study for?

This study is for advanced stomach, gastro-oesophageal junction, oesophageal, and pancreatic cancers.

Will I get the new medicine or a placebo?

Everyone in this study will receive the active medicine, AZD5863; there is no placebo.

How will the medicine be given?

The medicine will either be given into a vein (like a drip) or as an injection under the skin.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your future medical care.

How to find out more

AstraZeneca Clinical Study Information Center

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 "Study of AZD5863 in Adult Participants With Advanced or Meta…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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