A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma
This study is investigating a new treatment for advanced pancreatic cancer that has spread to other parts of the body. It combines an experimental drug, telisotuzumab adizutecan, with a commonly used chemotherapy mix called FOLFOX. Researchers want to see if this new combination is more effective and safe compared to the standard treatments currently available. The study will involve a large number of adult patients worldwide and will take place in two main stages. Initially, different doses of the new drug will be tested to find the best amount to use. Later, this best dose will be directly compared against the standard treatment options. The aim is to find better ways to help people with this type of cancer.
At a glance
What is this study about?
When cells in a part of the body grow out of control, it's called cancer. Pancreatic cancer often starts in the tubes (ducts) that carry digestive fluid from the pancreas to the gut. If this cancer spreads to other parts of the body, it’s called metastatic pancreatic ductal adenocarcinoma.
This research study is looking into a new treatment for adults with this type of advanced pancreatic cancer. The treatment involves an experimental drug called telisotuzumab adizutecan, given together with a standard chemotherapy combination known as FOLFOX. The main aims are to see how safe this combination is, what side effects it might cause, and if it can help slow down or reduce the cancer compared to the treatments doctors usually give.
The study will have two main parts, called Phase 2 and Phase 3. In Phase 2, a small group of patients will receive increasing doses of telisotuzumab adizutecan with FOLFOX to find the safest and most effective dose. Then, patients will be randomly assigned to different groups: some will get the new drug combination, and others will get the standard treatment. In Phase 3, a larger group of patients will compare the best dose of the new treatment against the standard care. About 900 people worldwide are expected to take part over approximately six years.
Key takeaways
- Tests a new drug (telisotuzumab adizutecan) with standard chemotherapy for advanced pancreatic cancer.
- Compares the new combination to usual treatments to see if it's better.
- Involves adults aged 18 and over with pancreatic cancer that has spread.
- Requires regular hospital visits and detailed health checks.
- The study will last approximately 6 years and involve many patients worldwide.
Who may be eligible?
This study is for adults aged 18 and over who have pancreatic cancer that has spread (metastatic) and cannot be removed by surgery. You would need to be well enough for daily activities, as measured by a doctor, and have cancer that can be measured on scans.
There are some reasons why you might not be able to join. For example, if you've already had certain cancer treatments like chemotherapy, surgery, or radiation for your advanced cancer (unless it was for pain relief). Also, if you’ve had particular types of lung disease, a bone marrow or organ transplant, or certain infections like tuberculosis, you would likely not be able to take part.
To check if you might be suitable, doctors will look at your medical history, any previous treatments, and scan results. They will also need a sample of your cancer tissue, either an existing one or a new one, to ensure it meets the study's requirements.
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 pancreatic cancer that has spread and doctors say can't be removed with surgery?
- Are you generally well enough for daily activities?
- Have you *not* had chemotherapy, surgery, or radiation for your advanced cancer (unless it was for pain relief)?
- Have you *not* had certain lung diseases, bone marrow/organ transplants, or specific infections?
- Can you provide a sample of your cancer tissue?
What does participation involve?
If you decide to take part in this study, you will have regular visits to a hospital or clinic. These visits will be more frequent than if you were receiving standard care. During these appointments, the study team will carry out various checks including medical assessments, blood tests, and questionnaires to see how you are feeling and if the treatment is working. They will also carefully monitor any side effects you might experience.
The treatment itself will involve receiving a combination of the experimental drug (telisotuzumab adizutecan) and chemotherapy (FOLFOX) through a drip into your vein. The specific drugs and doses will depend on which group you are assigned to. For example, some groups will receive the new drug with FOLFOX, while others will receive the standard treatment which includes different chemotherapy drugs.
The study is expected to run for about six years. You will be closely monitored throughout your participation to ensure your safety and to track how the treatment is affecting your cancer and your general health over this period.
Potential risks and benefits
Locations (18)
- City Of Hope - Chicago /ID# 279814Verified postcodeZion, United States· Recruiting
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853Verified postcodeGrand Rapids, United States· Recruiting
- Texas Oncology - Northeast Texas /ID# 280417Verified postcodeTyler, United States· Recruiting
- Virginia Cancer Specialists - Fairfax /ID# 280415Verified postcodeFairfax, United States· Recruiting
- Tamworth Hospital /ID# 280099Verified postcodeNorth Tamworth, Australia· Not yet recruiting
- Prince Of Wales Hospital - Randwick /ID# 280085Verified postcodeRandwick, Australia· Not yet recruiting
- Monash Health - Monash Medical Centre - Clayton /ID# 280076Verified postcodeClayton, Australia· Not yet recruiting
- Fiona Stanley Hospital /ID# 280079Verified postcodeMurdoch, Australia· Not yet recruiting
- The Chaim Sheba Medical Center /ID# 279408Verified postcodeRamat Gan, Israel· Recruiting
- Tel Aviv Sourasky Medical Center /ID# 279414Verified postcodeTel Aviv, Israel· Recruiting
- Rambam Health Care Campus- Haifa /ID# 279409Verified postcodeHaifa, Israel· Recruiting
- Hadassah Medical Center-Hebrew University /ID# 279411Verified postcodeJerusalem, Israel· Recruiting
Common questions
What is metastatic pancreatic cancer?
It's a type of pancreatic cancer that has spread from where it started to other parts of your body.
What is telisotuzumab adizutecan?
It's an new, investigational drug being tested in this study for pancreatic cancer. It's not a standard treatment yet.
Why is the study split into phases?
The different phases help researchers carefully find the best dose and then compare the new treatment against standard care in more people.
Will I know which treatment I'm getting?
In some parts of the study, you might be randomly assigned to a treatment group, and you might not know if you're getting the experimental drug or standard practice until later.
How long would I be in the study?
The entire study is expected to last about 6 years. Your personal involvement duration would be discussed with the study team.
How to find out more
ABBVIE CALL CENTER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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