A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
This research study is investigating a new treatment for people with advanced gastrointestinal (GI) cancers, which include cancers of the stomach, bowel, pancreas, and bile ducts. The treatment being tested is called raludotatug deruxtecan (R-DXd), and it’s a special type of drug designed to target cancer cells more directly. Imagine it like a guided missile that attaches to something specific on cancer cells and then delivers the medicine to destroy them. The main goal of this study is to find out if this new medicine makes the cancer smaller or makes it go away. This is a Phase 2 study, which means it’s looking at how well the treatment works and if it's safe in a larger group of people, after earlier studies have shown promising results.
At a glance
What is this study about?
This study is researching a new medicine for people who have advanced gastrointestinal (GI) cancers. These are cancers that affect parts of your digestive system, such as the pancreas, bile ducts, bowel (colon and rectum), stomach, or where your food pipe (oesophagus) joins your stomach. In this study, 'advanced' means the cancer cannot be removed by surgery or has spread to other parts of the body.
The medicine being tested is called raludotatug deruxtecan, often shortened to R-DXd. It's a clever type of drug called an 'antibody-drug conjugate' (ADC). You can think of an ADC as having two parts: one part acts like a guide that finds and attaches to specific proteins on cancer cells, and the other part is a powerful medicine that gets delivered directly into those cancer cells to destroy them. This approach aims to reduce harm to healthy cells while targeting cancer.
The main aim of this study is to see how well R-DXd works. Researchers will be looking to see if the cancer shrinks, stops growing, or even disappears. This is an important step in finding new and more effective treatments for challenging cancers.
Key takeaways
- Tests a new medicine (R-DXd) for advanced GI cancers.
- R-DXd aims to target cancer cells specifically.
- Main goal is to see if cancer shrinks or disappears.
- Involves regular clinic visits, tests, and scans.
- Potential for benefits, but also possible side effects.
Who may be eligible?
To be considered for this study, you would generally need to have a specific type of advanced gastrointestinal cancer, such as pancreatic, bile duct, bowel, or stomach cancer, that doctors cannot remove with surgery or has spread. You must also have already received some treatment for your cancer in the past.
There are also some health conditions that would mean you couldn't join the study. For example, if you have certain lung problems (like a history of severe lung inflammation), serious heart conditions, or other active cancers that are still growing or have needed recent treatment, you might not be able to take part. Also, if you have an autoimmune disease that has needed strong medication recently, or if you've recently had major surgery, you might be excluded.
If you have HIV, you might still be able to join if your HIV infection is well-controlled with medication. The doctors running the study will carefully check all these points to make sure the study is safe and suitable 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.
- Do I have an advanced pancreatic, bile duct, bowel, or stomach cancer?
- Have I already had some treatment for my cancer?
- Do I have any severe lung or heart conditions?
- Have I had any other cancers that are active or needed treatment recently?
- Is my HIV well-controlled if I am HIV positive?
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, raludotatug deruxtecan (R-DXd). The doctors and nurses will closely monitor your health and the effects of the treatment. This will involve regular visits to the clinic for check-ups, blood tests, scans (like CT or MRI scans) to see how your cancer is responding, and to check for any side effects.
You'll also have physical exams and discussions with the study team about how you're feeling. The frequency and duration of these visits will be explained in detail by the study team, but generally, studies like this involve regular appointments for many months, and sometimes follow-up for longer, even after you stop receiving the study medicine. Throughout the study, the team will ensure you understand what's required at each step.
Potential risks and benefits
Locations (41)
- Yale New Haven Hospital ( Site 0375)Verified postcodeNew Haven, United States
- Sibley Memorial Hospital ( Site 0372)Verified postcodeWashington D.C., United States
- Mt Sinai Comprehensive Cancer Center ( Site 0345)Verified postcodeMiami Beach, United States
- St. Vincent Healthcare Frontier Cancer Center ( Site 0347)Verified postcodeBillings, United States
- Morristown Medical Center ( Site 0349)Verified postcodeMorristown, United States
- University Hospitals Cleveland Medical Center ( Site 0369)Verified postcodeCleveland, United States
- University of Virginia Cancer Center ( Site 0365)Verified postcodeCharlottesville, United States
- University of Wisconsin Carbone Cancer Center ( Site 0348)Verified postcodeMadison, United States
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001)Verified postcodeMar del Plata, Argentina
- Nefra Medical Care - CEMIC Saavedra ( Site 0008)Verified postcodeBuenos Aires, Argentina
- Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)Verified postcodeRosario, Argentina
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0006)Verified postcodeLa Rioja, Argentina
Common questions
What does 'gastrointestinal cancer' mean?
Gastrointestinal cancers are cancers that affect parts of your digestive system, such as the stomach, bowel, pancreas, or bile ducts.
What is raludotatug deruxtecan (R-DXd)?
It's a new type of medicine that's designed to deliver treatment directly to cancer cells while trying to protect healthy cells.
What is a 'Phase 2' study?
A Phase 2 study checks how well a new medicine works and looks more closely at its safety in a larger group of people, after earlier studies have shown it to be promising.
Will I still receive my normal cancer treatment?
This study is testing a new treatment. If you join, you would receive the study medicine. However, the study team will discuss how this fits with any previous or ongoing treatments.
What if I change my mind about being in the study?
You are free to stop participating in the study at any time, for any reason. Your decision will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.