A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9
This study is testing a new drug called BNT329 for people with advanced solid cancers that have a specific marker called CA19-9. Advanced cancers mean they've spread or can't be cured with standard treatments. The main goals are to check how safe BNT329 is and to find the best dose. We'll also see how well it works by looking at whether it shrinks tumors or stops them from growing for a period. Researchers will also study how the drug moves through the body. This trial includes different stages to carefully test the drug's safety and potential benefits.
At a glance
What is this study about?
This research study is looking into a new treatment called BNT329. It's designed for people who have advanced solid cancers that produce a specific substance known as CA19-9. Advanced cancers are those that have spread or are difficult to treat with usual methods. The drug BNT329 is a special type of medicine called a monoclonal antibody, which is designed to target and attack cancer cells that have this CA19-9 marker.
The study has several important aims. Firstly, the researchers want to make sure BNT329 is safe for people to take. They will carefully watch for any side effects and how serious they might be. Secondly, they want to find the best dose of the drug – one that is effective but also has manageable side effects. Finally, they'll be checking how well BNT329 works against the cancer. This includes seeing if it can shrink tumors or stop them from growing and spreading for a period of time. They will also learn how the drug acts inside the body, like how it's absorbed and removed.
The study is split into different parts. The first parts will focus on finding the safest and most effective dose. These parts will include people with various types of advanced cancers that have the CA19-9 marker, such as pancreatic, bile duct, bladder, bowel, and ovarian cancers, where other treatments haven't worked well. A later part will specifically focus on pancreatic cancer, aiming to further understand the drug's benefits.
Key takeaways
- This study is testing a new drug for advanced cancers with a specific marker (CA19-9).
- It aims to find the safest dose and see how well the drug works.
- Different types of advanced cancers, including pancreatic, are included.
- You must have tried standard treatments that haven't worked or are unsuitable.
- Participation involves regular clinic visits and long-term follow-up.
- You can stop taking part in the study at any time.
Who may be eligible?
To join this study, your doctor will need to check if you meet certain requirements. Generally, you need to be 18 years or older. Your cancer should be considered 'advanced,' meaning it has spread or previous treatments haven't been successful, and it must show the CA19-9 marker. You should also be well enough to take part, meaning you can mostly look after yourself and spend less than half your waking hours in bed, and your important body organs like your liver and kidneys are working adequately.
Specifically for the first parts of the study, your advanced cancer usually needs to be one of these types: pancreatic, bile duct, bladder, bowel, stomach/oesophageal junction, womb lining (endometrial), or ovarian cancer. For these cancers, you should have already tried standard treatments available to you, and they haven't worked or are no longer suitable.
In a later part of the study focused only on pancreatic cancer, you would need to have already received at least one course of treatment for advanced pancreatic cancer. You cannot be currently in another study using an investigational drug. Your study doctor will review all your medical information to confirm if this trial 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.
- Are you 18 years of age or older?
- Do you have an advanced solid cancer that has the CA19-9 marker?
- Have you already tried standard treatments for your cancer, and they either haven't worked or are no longer an option?
- Are you generally well enough to manage your daily activities and not spend most of your day in bed?
- Are your major organs (like kidneys and liver) working reasonably well?
- Are you currently not involved in another medical study testing a new drug?
What does participation involve?
If you decide to take part, you'll first have a 'screening period' where doctors will do tests to see if you're suitable. If you are, you’ll then enter the 'treatment period,' which could last for up to two years. During this time, you will receive the study drug, BNT329. Depending on which part of the study you are in, you might be given a specific dose, or you might be placed into one of two groups by chance (like flipping a coin) to compare different dose levels.
Throughout the treatment period, you'll have regular visits to the clinic for assessments to see how you're responding to the treatment, if you're experiencing any side effects, and if the drug is affecting your body in other ways. After your treatment finishes, you will have two 'safety follow-up visits' to check on your health. There will also be a longer 'survival follow-up period,' where the researchers will keep in touch to understand your long-term health. You can stop participating at any time.
Potential risks and benefits
Locations (10)
- Florida Cancer SpecialistsVerified postcodeOrlando, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
- St. Josef-Hospital im Katholischen Klinikum BochumVerified postcodeBochum, Germany· Recruiting
- Universitaetsklinikum UlmVerified postcodeUlm, Germany· Recruiting
- Hospital Universitari Vall d'HebronVerified postcodeBarcelona, Spain· Recruiting
- Hospital San PedroVerified postcodeLogroño, Spain· Recruiting
- Hospital Universitario HM Sanchinarro - START Madrid CIOCCVerified postcodeMadrid, Spain· Recruiting
- Hospital Universitario Quironsalud Madrid - NEXT OncologyVerified postcodePozuelo de Alarcón, Spain· Recruiting
- Northern Centre for Cancer ResearchVerified postcodeNewcastle upon Tyne, United Kingdom· Recruiting
- The Royal Marsden HospitalVerified postcodeSutton, United Kingdom· Recruiting
Common questions
What is CA19-9?
CA19-9 is a specific type of marker or substance found on some cancer cells. This study drug, BNT329, is designed to target cells that have this marker.
What does 'advanced solid tumors' mean?
This means cancers that are not blood cancers, have grown beyond their original location, and may have spread to other parts of the body, making them harder to treat with standard methods.
Will I know if I'm getting BNT329, or a placebo?
This study does not use a placebo. All participants in the treatment parts will receive the investigational drug BNT329, though some groups may receive it at different doses or schedules.
How long will I be in the study?
The treatment part of the study can last up to two years. After that, there are follow-up visits and a long-term follow-up to check your health.
Can I continue my regular cancer treatment while in this study?
Generally, no. This study is for people where standard treatments haven't worked or are not suitable. You cannot be receiving other anti-cancer treatments during the study.
How to find out more
BioNTech clinical trials patient information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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