Active not recruitingPHASE3INTERVENTIONAL

AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

This research trial is looking at a new treatment called AZD0901 for a type of advanced cancer affecting the stomach or where the oesophagus (food pipe) joins the stomach. This study is for people whose cancer has already been treated at least once and has a specific protein called Claudin18.2 on its cells. The main goal is to find out if AZD0901 is more effective and safer than standard treatments chosen by doctors. Participants will be organised into groups, and some will receive AZD0901, while others will have existing treatments like Ramucirumab combined with paclitaxel, or other chemotherapy drugs. This is a Phase 3 trial, meaning it's one of the final steps before a medicine might be approved for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

592

Start

04 Mar 2024

Estimated completion

14 Oct 2026

Gastric Cancer Gastroesophageal Junction Cancer

What is this study about?

This research study is about finding a new and better way to treat advanced stomach cancer or cancer that affects the area where your food pipe joins your stomach. This type of cancer is called gastric or gastroesophageal junction adenocarcinoma. The researchers are particularly interested in patients whose cancer cells have a specific protein called Claudin18.2 on their surface. They want to see if a new drug, AZD0901, can help these patients, especially if their cancer has already been treated with other medicines and has come back or worsened.

The study will compare AZD0901 with treatments that doctors usually choose for these types of cancers. These standard treatments might include well-known chemotherapy drugs like Ramucirumab with paclitaxel, or others such as Docetaxel or Irinotecan. By comparing the new drug with existing treatments, doctors hope to understand if AZD0901 can shrink tumours more effectively, slow down the cancer's growth, and importantly, improve patients' quality of life and how long they live, while also checking for any side effects.

This is a `Phase 3` trial, which means it’s a large study involving many patients across different hospitals. This phase is important because it confirms the drug's safety and effectiveness compared to existing treatments before it can be considered for general use. The study also helps develop a test to identify patients who are most likely to benefit from AZD0901 by checking for the Claudin18.2 protein, ensuring the right treatment gets to the right person.

Key takeaways

This study is for advanced stomach or oesophageal junction cancer.
It tests a new drug, AZD0901, against standard treatments.
Participants must have Claudin18.2 protein on their cancer cells.
You must have already received at least one prior treatment for advanced cancer.
It's a Phase 3 study, aiming to evaluate effectiveness and safety.
Participation involves regular hospital visits, tests, and closely monitoring.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have advanced or spreading cancer of the stomach or where the food pipe meets the stomach. Your cancer cells must show a specific protein named Claudin18.2. You must have already received at least one course of treatment for your advanced cancer, which typically included certain chemotherapy drugs (fluoropyrimidine and a platinum).

There are also other health checks: your overall health needs to be good enough to take part (doctors use a scale called ECOG, and you'd need a score of 0 or 1), and you should have adequate organ function. Doctors also need to see at least one measurable area of your cancer. If you have known HER2 positive cancer, serious stomach bleeding, untreated stomach ulcers, or certain brain conditions, you would not be able to join this 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 advanced stomach or oesophageal junction cancer?
Does your cancer have the Claudin18.2 protein?
Have you already had at least one treatment for your advanced cancer?
Are you generally well enough for a clinical trial (ECOG 0 or 1)?
Are you free from certain other serious health problems like untreated stomach ulcers or specific brain conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have some screenings to see if you meet all the requirements. This will involve reviewing your medical history, having blood tests, and possibly biopsies, and imaging scans. If you qualify, you will be randomly assigned to receive either the new drug AZD0901 or one of the standard treatments for your type of cancer. This means neither you nor your doctor can choose which treatment you get; it’s decided by chance, like flipping a coin.

Throughout the study, you will have regular hospital visits for treatment, blood tests, scans (like CT scans) to check how well the treatment is working, and to monitor for any side effects. The exact number of visits and tests will depend on your treatment and how you are responding. You will continue treatment for as long as it is benefiting you and you are not experiencing severe side effects. After your treatment period, there will be follow-up appointments to monitor your health and long-term effects.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new investigational treatment (AZD0901) that might be more effective than current options, or receiving close monitoring and care from a specialist medical team. However, like all medicines, AZD0901 and the standard treatments carry potential risks of side effects. These can vary from mild to severe, and your medical team will discuss all known potential risks with you in detail. There is also the chance that the study treatment may not work for you, or that your cancer may not respond. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care or relationship with your healthcare team.

Locations (158)

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

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Mobile, United States
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Tucson, United States
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Duarte, United States
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Irvine, United States
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Los Angeles, United States
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Los Angeles, United States
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Newport Beach, United States
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Washington D.C., United States
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Hollywood, United States
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Orlando, United States
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Marietta, United States
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Boise, United States

Common questions

What is Claudin18.2?

Claudin18.2 is a special protein found on the surface of some cancer cells, particularly in certain stomach and oesophageal cancers. This study explores if a new drug can specifically target cells with this protein.

What does 'investigator's choice of therapy' mean?

This means that if you're in the comparison group, you'll receive one of the standard, approved treatments for your cancer, chosen by your doctor based on what's best for you and common practice.

What does Phase 3 mean?

Phase 3 is usually the final step for a new medicine before it might be approved. It's a large study, comparing the new treatment to existing ones to make sure it's safe and works well.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctor will know whether you are receiving AZD0901 or one of the standard treatments.

What if I experience side effects?

Your medical team will closely monitor you for any side effects. You should report any new or worsening symptoms immediately so they can be managed effectively and safely.