RecruitingPHASE1, PHASE2INTERVENTIONAL

Study for AZD4360 in Participants With Advanced Solid Tumours

This study is looking into a new treatment called AZD4360 for adults with advanced solid cancers, specifically stomach, gastroesophageal junction, bile duct, or pancreatic cancers. These cancers must show a particular marker called CLDN18.2. The main goals are to understand how safe the drug is, how much of it stays in the body, how the body reacts to it, and if it shows any signs of shrinking tumors. This research is being done in two stages (Phase 1 and Phase 2). Participants would have already received at least one other treatment for their cancer. The study hopes to find new and more effective ways to treat these types of cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

117

Start

29 Apr 2025

Estimated completion

16 Dec 2027

Gastric Cancer Gastroesophageal Junction Cancer Biliary Tract Cancer Pancreatic Ductal Adenocarcinoma

What is this study about?

This research study is about a new drug called AZD4360. It's being tested for adults who have advanced forms of certain cancers, specifically stomach cancer, cancer where the food pipe meets the stomach, bile duct cancer, and a type of pancreatic cancer. Doctors involved in this study will check if these cancers have a specific marker called CLDN18.2. This marker helps them decide if AZD4360 could be a suitable treatment for that person.

The main reasons for doing this study are to see if AZD4360 is safe for people to take and to understand how their bodies handle the drug. Researchers will also look for any early signs that the drug might be helping to shrink the tumors. This is an important step in developing new medicines, as it helps us learn if a new treatment works and if it's safe enough to be studied more widely.

Finding new ways to treat advanced cancers is very important. This study offers a chance for some patients to try a new treatment that isn't yet widely available. It helps medical science move forward, potentially leading to better options for people with these conditions in the future.

Key takeaways

This study tests a new drug, AZD4360, for specific advanced cancers.
It focuses on stomach, bile duct, and pancreatic cancers with a 'CLDN18.2' marker.
The main goals are to check safety and see early signs of effectiveness.
Participants must have tried at least one other treatment for their cancer already.
You would receive close monitoring and care if you join.

Who may be eligible?

To join this study, you generally need to be an adult over 18 years old. You should also be well enough to take part, meaning you can mostly go about your daily activities without too much difficulty. Your doctors will check that your important body organs, like your kidneys and liver, are working well enough, and they'll confirm that you are expected to live for at least another 12 weeks.

Your cancer must be advanced stomach, gastroesophageal junction, bile duct, or pancreatic cancer that has spread, and it must show a specific marker called CLDN18.2. You should have already tried at least one other treatment for your advanced cancer, and doctors need to be able to measure at least one of your tumors.

There are also reasons why you might not be able to join. For example, if you have certain types of heart problems, active infections like uncontrolled HIV, or severe ulcers or bleeding in your digestive system, you might not be eligible. If you have cancer that has spread to your brain or spinal cord, or certain lung conditions, you might also not be able to take part. The study team will review all your health information carefully to see if this study is suitable 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.

Are you 18 years old or older?
Do you have advanced stomach, gastroesophageal junction, bile duct, or pancreatic cancer?
Has your doctor confirmed your cancer has the CLDN18.2 marker?
Have you already had at least one other treatment for your advanced cancer?
Are you generally well enough for daily activities?
Are your major organs (like liver, kidneys) working reasonably well?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new drug AZD4360 as part of your treatment plan. The study team would closely monitor your health with regular check-ups, blood tests, and scans to see how you're responding to the treatment and to check for any side effects. You would have scheduled visits to the hospital or clinic for these assessments and to receive the medication.

The exact number of visits and the full duration of your participation would depend on how your body reacts to the treatment and if the drug continues to be helpful. Some people might be in the study for a shorter time, while others might participate for longer. The study team will explain all the details, including the schedule of visits, assessments, and follow-up care that would be involved if you join this trial.

Potential risks and benefits

Taking part in any clinical study means there might be potential benefits and potential risks. A possible benefit is that AZD4360 might help treat your cancer, potentially slowing its growth or shrinking tumors, though this is not guaranteed as it's a new drug being tested. You would also receive close medical attention and monitoring from the study team. Potential risks include experiencing side effects from the drug, which could range from mild to more serious; however, the study team will monitor you very closely. You always have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (18)

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

Research Site
Verified postcode
Santa Monica, United States· Recruiting
Research Site
Verified postcode
Providence, United States· Recruiting
Research Site
Verified postcode
Houston, United States· Recruiting
Research Site
Verified postcode
Beijing, China· Recruiting
Research Site
Verified postcode
Chengdu, China· Recruiting
Research Site
Verified postcode
Shanghai, China· Recruiting
Research Site
Verified postcode
Wuhan, China· Recruiting
Research Site
Verified postcode
Berlin, Germany· Not yet recruiting
Research Site
Verified postcode
Dresden, Germany· Recruiting
Research Site
Verified postcode
Frankfurt, Germany· Recruiting
Research Site
Verified postcode
Chūōku, Japan· Recruiting
Research Site
Verified postcode
Kashiwa, Japan· Recruiting

Common questions

What is AZD4360?

AZD4360 is a new drug being tested in this study to see how it affects certain advanced cancers.

What does 'advanced' cancer mean in this study?

It means the cancer has spread from where it started (metastatic) or has grown into nearby tissues (locally advanced).

What is the CLDN18.2 marker?

CLDN18.2 is a specific protein found on some cancer cells. The study drug is designed to target cells that have this marker.

Will I still get my usual cancer treatment?

You would receive AZD4360 as part of this study, and you will have already received other standard treatments beforehand.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, and it won't affect the care you receive from your doctors.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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