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RecruitingPHASE2INTERVENTIONAL

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

This research is testing a new drug named AZD0901 for people who have advanced cancers, such as stomach, bile duct, or pancreatic cancer, that have certain protein markers. The main goal is to understand how safe the new drug is, and if it helps to slow down or shrink these cancers. We're also looking at how the drug works in the body and if the body develops any reactions to it. Some people will get AZD0901 by itself, while others will get it along with other standard cancer treatments. This involves several smaller studies, each focusing on a different type of cancer and treatment combination to make sure we learn as much as possible about this new medicine.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
224
Start
13 Dec 2023
Estimated completion
30 Sep 2027

What is this study about?

This study is about a new medicine called AZD0901, which is being tested for certain types of advanced cancer. These cancers include stomach cancer, cancer where the stomach meets the food pipe, bile duct cancer, and a type of pancreatic cancer. Doctors are looking for a special marker on the cancer cells called CLDN18.2 – only people whose cancer has this marker can join the study.

The main purpose of this research is to see if AZD0901 is safe to use and if it can help treat these cancers. Scientists also want to learn how the body takes in and uses the medicine, and if the body's immune system reacts to it. Sometimes AZD0901 will be given on its own, and other times it will be combined with other cancer treatments that people might already be familiar with, like certain types of chemotherapy drugs.

Because different cancers are being studied, the research is split into a few smaller parts. For example, one part will focus on stomach cancer, another on pancreatic cancer, and another on bile duct cancer. By doing this, the researchers can carefully check the safety and effects of AZD0901 for each specific cancer type and treatment plan.

Key takeaways

  • This study is testing a new cancer medicine called AZD0901.
  • It's for people with advanced stomach, bile duct, or pancreatic cancers with a specific marker.
  • The study aims to check its safety and if it helps shrink or slow cancer.
  • AZD0901 may be given alone or with common chemotherapy drugs.
  • Your cancer needs to have a marker called CLDN18.2 to be considered.

Who may be eligible?

To join this study, you need to be at least 18 years old and your cancer cells must show a specific marker called CLDN18.2. You should also be generally well enough to take part, meaning you can mostly look after yourself and have a good predicted life expectancy. Your body's organs, like your kidneys and liver, need to be working well, and you must weigh more than 35 kg.

Beyond these general rules, there are specific requirements depending on your cancer type. For stomach or gastroesophageal junction cancer, you must have advanced disease and have had no more than two previous treatments for it. For pancreatic cancer, you can't have had any prior treatment for your advanced disease, but previous chemotherapy before your cancer spread is allowed if it was more than six months ago. For bile duct cancer, you need to have already had at least one treatment, but no more than two, and your cancer must have progressed despite those treatments.

There are also reasons why you might not be able to join, such as having certain other serious health conditions like active stomach ulcers or digestive bleeding. It's important to discuss your full medical history with the study team to see if you meet all the criteria.

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. Are you 18 years old or older?
  2. Do you have advanced stomach, bile duct, or pancreatic cancer?
  3. Does your cancer have the CLDN18.2 marker? (Your doctor can check this.)
  4. Are you generally well enough to go about your daily activities?
  5. Are your other organs (like kidneys, liver) working well?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study medicine, AZD0901, through a drip into your vein (intravenously). Depending on which part of the study you join, you might receive AZD0901 on its own or together with other cancer medicines. The study will involve regular visits to the hospital for these treatments, and doctors will perform various tests and assessments to monitor your health and how you respond to the treatment. This includes blood tests, scans, and physical examinations. The exact number of visits and the full duration of your participation will depend on how your treatment progresses and what part of the study you are in, but the team will explain everything to you in detail. You will be closely monitored throughout the study and during any follow-up period.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to a new medicine that isn't widely available yet, which might help your cancer when other treatments haven't. However, there are also possible risks. Like all medicines, AZD0901 could cause side effects, some of which might be serious. The study team will explain all the known and potential risks to you before you decide to join. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (52)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Orange, United States· Recruiting
  • Research Site
    Verified postcode
    Palo Alto, United States· Recruiting
  • Research Site
    Verified postcode
    Santa Rosa, United States· Recruiting
  • Research Site
    Verified postcode
    Louisville, United States· Recruiting
  • Research Site
    Verified postcode
    Commack, United States· Recruiting
  • Research Site
    Verified postcode
    Providence, United States· Recruiting
  • Research Site
    Verified postcode
    Houston, United States· Recruiting
  • Research Site
    Verified postcode
    Melbourne, Australia· Recruiting
  • Research Site
    Verified postcode
    Murdoch, Australia· Recruiting
  • Research Site
    Verified postcode
    Randwick, Australia· Recruiting
  • Research Site
    Verified postcode
    Kingston, Canada· Withdrawn
  • Research Site
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is AZD0901?

AZD0901 is a new medicine being tested in this study to see if it can help treat certain advanced cancers.

What types of cancer is this study for?

This study is for people with advanced stomach, gastroesophageal junction, bile duct, or pancreatic cancer that has a specific marker called CLDN18.2.

Will I get AZD0901 on its own or with other drugs?

That depends on which part of the study you join. Some people will get AZD0901 by itself, while others will get it with standard chemotherapy medicines.

How will I receive the medicine?

The medicine will be given to you through a drip into your vein, usually during hospital visits.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your 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 "AZD0901 in Participants With Advanced Solid Tumours Expressi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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