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RecruitingPHASE2INTERVENTIONAL

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

This research study, called DESTINY-Gastric03, is investigating new ways to treat advanced stomach or oesophageal cancer that has a protein called HER2. We are testing a medicine called trastuzumab deruxtecan (T-DXd). This drug might be given on its own, or combined with existing chemotherapy (drug treatment) or immunotherapy (treatment that helps your body’s immune system fight cancer). The main goals are to check if these treatments are safe, how well they are tolerated by patients, and if they show promise in shrinking tumours. We want to see if these new approaches could become good treatment options for people with this type of cancer.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
450
Start
03 Jun 2020
Estimated completion
01 Jun 2027

What is this study about?

This study is called DESTINY-Gastric03 and it's looking into new treatments for a type of advanced cancer that affects the stomach or the connection between the food pipe (oesophagus) and the stomach. This type of cancer has a specific protein called HER2 on its cells. You might hear this called HER2-expressing cancer. We're specifically interested in a new drug called trastuzumab deruxtecan (which we'll call T-DXd for short).

Researchers want to see if T-DXd, either on its own or teamed up with other common cancer medicines like chemotherapy or immunotherapy, can help people with this cancer. They will be carefully watching for two main things: safety – making sure the treatments don't cause too many serious side effects – and how well they are tolerated. They'll also be looking for early signs that the treatments are effective in stopping cancer growth or shrinking tumours.

The hope is that if these new treatment combinations prove to be safe and show good results, they could offer more options for people living with advanced stomach or oesophageal cancer in the future. This study is an important step in understanding these potential new therapies.

Key takeaways

  • Investigating new treatments for advanced stomach/oesophageal cancer with HER2 protein.
  • Testing trastuzumab deruxtecan (T-DXd) alone or with other approved cancer drugs.
  • Main goals are to check safety, tolerability, and early signs of tumour shrinkage.
  • Could provide new treatment options if successful.
  • Open to patients aged 18 and over with specific cancer types and good general health.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have advanced cancer in your stomach or the connection between your food pipe and stomach (called the GEJ) that can't be removed with surgery, or cancer that has spread to other parts of your body. Your cancer cells must also show the HER2 protein, either at high levels (called HER2-positive) or lower levels (called HER2-low).

Depending on which part of the study you might join, you may have already had some treatment for your cancer, or you might be starting treatment for the first time. The doctors will need to be able to measure your tumour to see if the treatment is working. It's also important that your body is generally well and your organs, like your heart, kidneys, and liver, are working properly. If you can become pregnant, you'll need to agree to use effective birth control during and after the study.

There are also some reasons why you wouldn't be able to join. For example, if you have certain infections like active HIV, Hepatitis B, or C, or if you have a history of a specific lung condition called pneumonitis or other serious lung problems. Uncontrolled infections or certain fluid build-ups around your lungs or heart would also prevent you from joining. The study team will review all your medical information carefully to see if this study 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. Are you at least 18 years old?
  2. Do you have advanced stomach or oesophageal cancer that has the HER2 protein?
  3. Can your tumour be measured by scans?
  4. Is your general health, including your heart, kidneys, and liver, in good condition?
  5. Are you willing to use effective birth control if you can become pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital for checks and treatments. During these visits, doctors and nurses will monitor your health very closely. This will include physical exams, blood tests, and scans (like CT or MRI scans) to see how your body is responding to the treatment and if the cancer is changing. You will be given the study medication (trastuzumab deruxtecan, either alone or with other medicines) as prescribed by the study doctors. The exact number of visits and the duration of your participation will depend on how you respond to the treatment and which part of the study you are in. Researchers will keep checking on your health even after the main treatment ends, which is called follow-up. This is done to understand the long-term effects of the treatment.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as accessing new treatments not yet widely available, which could be more effective for your condition. However, there are also potential risks involved. The treatments being tested are investigational, meaning their full effects and side effects are not yet completely known. You might experience side effects from the medications, which could range from mild to severe. The medical team will monitor you closely for any issues, but there's no guarantee the treatment will work for you. It's important to remember that participating in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (100)

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· Withdrawn
  • Research Site
    Verified postcode
    Westwood, United States· Withdrawn
  • Research Site
    Verified postcode
    Baltimore, United States· Recruiting
  • Research Site
    Verified postcode
    Boston, United States· Withdrawn
  • Research Site
    Verified postcode
    Boston, United States· Recruiting
  • Research Site
    Verified postcode
    Ann Arbor, United States· Withdrawn
  • Research Site
    Verified postcode
    New York, United States· Recruiting
  • Research Site
    Verified postcode
    Durham, United States· Withdrawn
  • Research Site
    Verified postcode
    Houston, United States· Recruiting
  • Research Site
    Verified postcode
    Fairfax, United States· Withdrawn
  • Research Site
    Verified postcode
    Florianópolis, Brazil· Withdrawn
  • Research Site
    Verified postcode
    Londrina, Brazil· Completed

Common questions

What is HER2-expressing cancer?

HER2-expressing cancer means that cancer cells have a particular protein called HER2 on their surface. This protein can encourage cancer cells to grow.

What is trastuzumab deruxtecan (T-DXd)?

T-DXd is a new type of cancer drug being tested. It's designed to deliver a powerful medicine directly to cancer cells that have the HER2 protein.

What's the difference between HER2-positive and HER2-low?

Both mean your cancer has the HER2 protein, but HER2-positive means there's a higher amount, and HER2-low means there's a smaller but still present amount of the protein.

Will I receive an established treatment or an experimental one?

Some participants might receive T-DXd on its own or combined with other, already approved, cancer treatments (like chemotherapy or immunotherapy).

How long will I be in the study?

The length of your participation will vary. It depends on how your body responds to the treatment and how the study progresses, but you will have ongoing follow-up.

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 "Ph1b/2 Study of the Safety and Efficacy of T-DXd Combination…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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