A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
This study is looking at a new medicine called BNT326 for people with advanced cancers that have either spread or come back after previous treatments. It's a two-part study. Part 1 tests BNT326 on its own in different types of advanced solid tumours, including melanoma and lung cancer. Part 2 tests BNT326 along with another investigational medicine called pumitamig in a range of advanced cancers, such as breast cancer, stomach cancer, and cervical cancer. Researchers want to find out if these medicines are safe, how well they work, the best dose to use, and how the body handles them. The goal is to help find better ways to treat these cancers.
At a glance
What is this study about?
This research study is about investigating a new medicine called BNT326, which is still in development. It's designed for people who have advanced solid tumours – that means cancers which have either spread to other parts of the body (metastatic) or have returned after previous treatments. The study aims to understand if BNT326 is safe to use and whether it could be helpful in treating these cancers. It's also looking at finding the best dose of the medicine.
The study is split into two main parts. In the first part, participants will receive BNT326 on its own. This includes people with different types of advanced cancers like certain skin cancers (melanoma), lung cancer, and cervical cancer. In the second part, BNT326 will be given together with another investigational medicine called pumitamig. This combination will be tested in other advanced cancers, including breast cancer, stomach cancer, and bowel cancer. The researchers want to see how these medicines work alone and together.
It's important to remember that these are new medicines, and we don't yet know for sure how effective they will be. This study is a crucial step in gathering more information to see if they could offer new treatment options for patients in the future. The study will carefully monitor all participants.
Key takeaways
- This study is testing a new cancer medicine, BNT326, and sometimes with another medicine called pumitamig.
- It's for people with advanced cancers that have spread or come back after earlier treatments.
- The main goals are to find out if the treatments are safe, how well they work, and the best dose.
- The study is in early stages (Phase 1 and 2), which means the medicines are still being investigated.
- Participants will have regular check-ups and monitoring by the study team.
- You can discuss with your doctor if this study might be suitable for you.
Who may be eligible?
To join this study, participants generally need to be at least 18 years old. You must have advanced cancer that has spread or returned, and your doctor must have confirmed this with tests. The study needs a recent tissue sample from your tumour, either new or from old records.
Your general health needs to be good enough to take part, and your organs should be working well. Specific groups of participants will be needed for different parts of the study. For example, some parts are for people with melanoma who have already tried other treatments, or people with certain types of lung cancer.
Your doctor will check if your specific cancer type and previous treatments match the requirements for any of the study groups. There are also detailed medical criteria that your doctor will review to make sure this study 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 old or older?
- Do you have an advanced solid tumour that has spread or returned?
- Did your doctor confirm your cancer diagnosis with a tissue sample?
- Do you have generally good health as assessed by your doctor?
- Are you willing to provide a tumour tissue sample (if you haven't already)?
- Have you discussed your previous cancer treatments with your doctor?
What does participation involve?
If you decide to take part in this study, you will be given an investigational medicine, either BNT326 on its own or in combination with pumitamig, depending on which part of the study you join. You might also be given other commonly used medicines like Itraconazole or Paroxetine, possibly to help with side effects or to understand how the study drugs interact with other medicines. The study duration will vary depending on your specific situation within the trial, but it will involve regular visits to the clinic for check-ups, tests, and to receive your medication. Medical staff will closely monitor your health throughout the study. The study is divided into different groups and treatment plans, and for some, the specific dose of BNT326 or the combination treatment will be decided by chance (like flipping a coin).
Potential risks and benefits
Locations (64)
- Mayo Clinic ArizonaVerified postcodePhoenix, United States· Not yet recruiting
- University of California San FranciscoVerified postcodeSan Francisco, United States· Not yet recruiting
- Hartford HealthcareVerified postcodeHartford, United States· Recruiting
- Yale UniversityVerified postcodeNew Haven, United States· Recruiting
- Florida Cancer SpecialistsVerified postcodeSarasota, United States· Recruiting
- Moffitt Cancer CenterVerified postcodeTampa, United States· Recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Not yet recruiting
- Massachusetts General HospitalVerified postcodeBoston, United States· Recruiting
- Brigitte Harris Cancer Pavilion BHCPVerified postcodeDetroit, United States· Not yet recruiting
- START Midwest, LLCVerified postcodeGrand Rapids, United States· Recruiting
- Memorial Sloan Kettering HospitalVerified postcodeNew York, United States· Recruiting
- Duke Cancer InstituteVerified postcodeDurham, United States· Not yet recruiting
Common questions
What does 'investigational treatment' mean?
It means the treatment is new and still being studied to see if it's safe and works well. It's not yet approved for general use by doctors.
What kind of cancers is this study for?
This study is for people with advanced solid tumours, which are cancers that have spread or come back after previous treatments. This includes various types like melanoma, lung, breast, stomach, and cervical cancer.
What is a 'Phase 1' or 'Phase 2' study?
Phase 1 studies mostly check if a new medicine is safe and find the right dose. Phase 2 studies then look at how well the medicine works and continue to check its safety in more people.
Will I definitely get the new medicine?
If you join the study, you will receive BNT326, either on its own or with another investigational treatment like pumitamig. The specific treatment plan depends on which detailed group you are in.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.
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?
Discussion
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