A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)
This study, called "DisTinGuish," is for adults with stomach cancer or cancer where the food pipe meets the stomach, especially when the cancer is advanced or has spread. It's a Phase 2 study, meaning it's testing new treatments to see if they're safe and effective. Researchers are trying a new drug called DKN-01 along with an existing drug, tislelizumab, and standard chemotherapy. Some patients will receive DKN-01 plus tislelizumab and chemotherapy, while others will receive only tislelizumab and chemotherapy. The main goal is to see how many side effects people have and how long people live without their cancer growing worse, particularly for those with a high level of a certain marker called DKK1 in their cancer.
At a glance
What is this study about?
This study is investigating new ways to treat stomach cancer or cancer that affects the area where your food pipe joins your stomach. These cancers are often quite advanced or have spread to other parts of the body when they are diagnosed.
The study is called "DisTinGuish" and it's a 'Phase 2' trial. This means it's still in the earlier stages of research, where doctors are closely watching how safe the new treatment combinations are and how well they work. It's not yet known if these new combinations are better than current treatments, but the hope is to find more effective options for patients.
Researchers are looking at a new drug called DKN-01, which is being tested in combination with another drug called tislelizumab, and standard chemotherapy treatments (like CAPOX or mFOLFOX6). Some participants will receive the DKN-01 combination, while others will receive tislelizumab and chemotherapy without DKN-01. The main points the doctors will be checking are how many side effects people experience and how long people live without their cancer growing worse. They are particularly interested in how these treatments work for patients whose cancer has a specific chemical marker called DKK1. This marker might help them understand who might benefit most from the new treatment.
Key takeaways
- This study is for advanced stomach or gastroesophageal junction cancer.
- It's testing a new drug (DKN-01) with existing treatments.
- The study checks for both safety (side effects) and effectiveness.
- Participation involves regular clinic visits, tests, and treatments.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be 18 years old or older. The study is open to both men and women.
You would be considered for this study if you have stomach cancer or cancer where your food pipe meets your stomach, and your cancer is advanced or has spread to other parts of your body. Your doctors will need to carefully review your medical history and test results to ensure the study is suitable for you.
There will be specific health requirements and other medical checks to make sure joining the study is safe for you. Your doctors will discuss all these details with 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 stomach cancer or cancer where your food pipe meets your stomach?
- Is your cancer advanced or has it spread?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Have you discussed your overall health with your doctor regarding suitability for a clinical trial?
What does participation involve?
If you decide to take part, you'll receive either a new combination of drugs (DKN-01, tislelizumab, and chemotherapy) or tislelizumab plus chemotherapy. The chemotherapy treatments used are standard ones like CAPOX or mFOLFOX6. You will have regular visits to the clinic for your treatments and check-ups. These check-ups will include blood tests, scans (like CT scans), and other medical examinations to see how you're responding to the treatment and to monitor for any side effects. The exact number of visits and the total duration aren't specified but will involve regular treatment cycles and follow-up. This will continue for as long as the treatment is helping you and you are not experiencing severe side effects.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is a Phase 2 study?
A Phase 2 study is a stage of clinical research where doctors test new treatments on a larger group of patients to see if it's safe and if it works for a specific condition. It helps them decide if the treatment should move on to bigger studies.
What does 'inoperable, locally advanced or metastatic' mean?
This means the cancer cannot be removed by surgery, or it has grown into nearby tissues, or it has spread to other parts of the body.
What is DKK1-high?
DKK1-high refers to a specific protein marker found in some cancer cells. Researchers are interested in whether treatments work differently for people with high levels of this marker.
Will I definitely receive the new drug DKN-01?
No, in some parts of the study, patients will be randomly assigned to receive DKN-01 along with other drugs, while others will receive the other drugs without DKN-01. Your study doctor will explain this in more detail.
What are the main things doctors are looking for in this study?
The main things are how safe the treatments are (side effects) and how effective they are at controlling the cancer and preventing it from growing worse.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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