All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

WaKING: Wnt and checKpoint INhibition in Gastric Cancer

This study, called WaKING, is looking at a new treatment for advanced stomach (gastric) or gullet (oesophageal) cancer that has spread to other parts of the body. This is for people who have already had standard chemotherapy. The study will test a combination of two drugs, DKN-01 and atezolizumab. Researchers want to find out if this combination is safe and if it can help slow down or shrink the cancer. The study is split into two parts: first, making sure the combination of drugs is safe, and then checking how well it works against the cancer. This is an important step in finding new ways to treat these types of cancer.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Royal Marsden NHS Foundation Trust
Enrolment target
52
Start
11 Feb 2020
Estimated completion
31 Dec 2025

What is this study about?

This study is called WaKING, which stands for Wnt and checKpoint INhibition in Gastric Cancer. It's designed for people who have advanced stomach (gastric) or gullet (oesophageal) cancer that is no longer responding to standard chemotherapy treatments and has spread to other parts of the body.

The main goal of this study is to explore a new treatment approach. Researchers are testing a combination of two new medicines: DKN-01 and atezolizumab. Atezolizumab is a type of immunotherapy that helps your body's immune system fight cancer. DKN-01 is a different type of drug that works in another way to potentially stop cancer growth. By combining these two medicines, doctors hope to find a more effective way to treat this cancer.

The study is taking place in different medical centres and will happen in two main stages. The first stage will carefully check the safety of giving these two drugs together and find the right dose. Once a safe dose is confirmed, the second stage will look at how well this combination treatment works against the cancer, meaning if it can shrink the cancer or stop it from growing. This research is vital for finding new and better ways to treat advanced stomach and gullet cancer.

Key takeaways

  • Tests a new combination of two drugs for advanced stomach/gullet cancer.
  • For patients whose cancer has grown despite chemotherapy.
  • Aims to find a safe dose and see if the treatment shrinks cancer.
  • Requires regular hospital visits for treatment and monitoring.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have advanced stomach or gullet cancer that has spread. You must have already tried at least one, and possibly two, types of chemotherapy for your advanced cancer, and it needs to have started growing again. Your cancer must also show a certain genetic make-up (MMR proficiency or MSI stability), which can be checked using a sample of your tumour.

You'll also need to be generally well enough to take part. This means your daily activities shouldn't be too limited by your illness, and your blood tests for important organs like your liver and kidneys need to be within a healthy range. Your doctor will assess your overall health to make sure it's safe for you to participate.

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 or gullet cancer that has spread?
  3. Have you already had at least one chemotherapy treatment for your advanced cancer and it has progressed?
  4. Is your ECOG score 0 or 1 (meaning you're fairly active and able to do most daily tasks)?
  5. Do your doctors think you have at least 3 months life expectancy?
  6. Do your blood tests show your major organs (liver, kidneys) are working well enough?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll receive the new combination treatment of DKN-01 and atezolizumab. The exact number of visits and tests will depend on the stage of the trial and your individual treatment plan, but you can expect regular hospital visits for drug administration, blood tests, and scans to monitor your health and how the treatment is working. This could include CT scans or other imaging tests.

You'll be carefully monitored for any side effects throughout the study. The total duration of your participation will vary, but it will involve treatment cycles and follow-up appointments. The initial part of the study focuses on safety, and once the safe dose is found, the study moves to checking how effective the treatment is. Your study doctor will explain the full schedule of visits, tests, and treatments.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, which could potentially help control your cancer. However, there's no guarantee the treatment will work for you, and it may not be better than existing options. There are also potential risks, as DKN-01 and atezolizumab can cause side effects, some of which could be serious. The study team will monitor you closely for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The Royal Marsden NHS Foundation Trust
    Verified postcode
    Sutton, United Kingdom

Common questions

What types of cancer is this study for?

This study is for advanced stomach (gastric) or gullet (oesophageal) cancer that has spread and hasn't responded to previous chemotherapy.

What are DKN-01 and atezolizumab?

They are experimental medicines being tested together. Atezolizumab is an immunotherapy, and DKN-01 works in a different way to target cancer growth.

Will I get this new treatment if I join?

Yes, if you're eligible and choose to join, you will receive the combination of DKN-01 and atezolizumab. It's not a placebo study.

What is the main purpose of the study?

To check if the combination of DKN-01 and atezolizumab is safe and effective in treating advanced stomach or gullet cancer.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and your regular medical care will not be affected.

How to find out more

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

Discussion

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