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A Study Testing BNT329 Safety and Effectiveness in Patients With Advanced Solid Tumors That Express the CA19-9 Tumor Marker

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at people with advanced solid cancers that are known to produce a tumor marker called CA19-9. The types of cancer included in this study are pancreatic adenocarcinoma, cancer of the bile ducts, cancer of the bladder and urinary tract, colorectal adenocarcinoma, cancer of the area where the esophagus meets the stomach, endometrial carcinoma, and epithelial ovarian cancer. The treatment being tested is an investigational drug called BNT329, which is given through an intravenous infusion, meaning it is delivered directly into a vein. The purpose of this study is to find out if BNT329 is safe and to see if it might help control or shrink these tumors.

The study is divided into different parts. In the first parts, called Part A, Part B, and Part C, researchers will test different doses of the drug to find out which dose is safe and works best. They will carefully watch for any side effects and see how the body processes the drug. In Part D, the study will focus specifically on people with pancreatic adenocarcinoma and will look more closely at whether the drug helps shrink tumors or stop them from growing. During the study, participants will receive the study drug and will have regular check-ups to monitor their health and see how the cancer is responding to treatment.

Throughout all parts of the study, doctors will measure how much of the drug is in the blood, watch for any unwanted effects, and check if the cancer gets better, stays the same, or gets worse. They will also test whether the body develops an immune response to the drug over time. The study will track how long any positive effects last and whether people need to stop treatment or change their dose because of side effects. All participants must have already tried standard treatments that are normally used for their type of cancer, and those treatments must not have worked well enough or must no longer be available as an option.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and confirmation of eligibility
Your medical history will be reviewed to confirm that you have an advanced solid tumor that expresses the CA19-9 tumor marker. CA19-9 is a protein found on the surface of certain cancer cells.
Your tumor type will be confirmed through previous tissue analysis. Eligible tumor types include pancreatic cancer, bile duct cancer, bladder cancer, colorectal cancer, esophagogastric junction cancer, endometrial cancer, and ovarian cancer.
Your disease will be measured using imaging scans to establish a baseline according to RECIST 1.1 criteria, which is a standard method for measuring tumor size. If you have ovarian cancer, different measurement criteria will be used.
Blood tests and other assessments will be performed to check your organ function, blood cell counts, and blood clotting ability to ensure they meet the required levels for participation.
Your life expectancy will be assessed and must be at least 3 months.
Step 2
Treatment with BNT329
You will receive BNT329, which is an investigational drug designed to target cancer cells that express the CA19-9 marker.
BNT329 will be given to you through an intravenous infusion, which means it will be administered directly into your vein over a period of time.
The dose of BNT329 you receive will depend on which part of the trial you are enrolled in. The trial is designed to test different dose levels to find the safest and most effective amount.
The frequency and duration of treatment will be determined by the specific protocol for your dose level and will continue as long as the treatment is considered safe and potentially beneficial for you.
Step 3
Monitoring for side effects and safety
Throughout the trial, you will be closely monitored for any adverse events, which are unwanted or harmful effects that may occur during treatment.
Special attention will be paid to dose-limiting toxicities, which are serious side effects that may require adjustment or stopping of your treatment.
Your treatment may be interrupted, the dose may be reduced, or treatment may be stopped entirely if you experience significant side effects.
Blood samples will be taken at regular intervals to measure the levels of the drug in your bloodstream and to assess how your body processes the medication.
Tests will also be conducted to check if your body develops an immune response to the drug, known as anti-drug antibodies.
Step 4
Assessment of treatment response
Regular imaging scans will be performed to measure changes in your tumor size and to determine how your cancer is responding to treatment.
Your response will be classified as complete response (tumor disappears completely), partial response (tumor shrinks), stable disease (tumor stays the same size for at least 6 weeks), or progressive disease (tumor grows).
The duration of your response, if one occurs, will be tracked from the time your tumor first responds until the time it grows again or until death from any cause.
Your overall disease control will be assessed, which includes whether your tumor shrinks, disappears, or remains stable during treatment.
Step 5
Continuation or completion of treatment
You will continue receiving BNT329 as long as the treatment is safe for you and your disease does not progress.
If your tumor grows despite treatment, if you experience unacceptable side effects, or if you decide to withdraw from the trial, your treatment will be stopped.
The trial is expected to continue until 2030, though your individual participation duration will depend on how you respond to treatment and whether you continue to meet the criteria for ongoing participation.

Who can join the trial?

7 criteria

You must be 18 years of age or older
You must have measurable disease, which means your tumor can be seen and measured on scans using specific measurement guidelines called RECIST 1.1, except for ovarian cancer which uses different measurement guidelines
Your doctor must believe you have a life expectancy of at least 3 months
Your organs must be working well enough, including your liver, kidneys, and bone marrow, and your blood must clot properly, as defined by specific test results in the study protocol
For certain parts of the study: You must have a type of advanced or metastatic cancer (cancer that has spread to other parts of the body) that is known to produce a protein marker called CA19-9. These cancer types include pancreatic cancer, bile duct cancer, bladder and urinary tract cancer, colorectal cancer, cancer of the area where the esophagus meets the stomach, endometrial cancer, or epithelial ovarian cancer
For certain parts of the study: You must have no standard treatment available that your doctor believes would help you. You must have already received all available standard treatments, including any targeted therapies based on your tumor's genetic changes, and at least your first standard treatment must not have worked
For one specific part of the study: You must have a confirmed diagnosis of pancreatic cancer (PDAC). You must have been offered all available standard treatments including targeted therapies based on your tumor's genetic changes. Established second-line treatments must not be withheld. Your cancer must have gotten worse on scans, and there must be no standard treatment available that your doctor believes would help you

Who cannot join the trial?

3 criteria

The specific exclusion criteria (reasons why patients cannot participate) have not been provided in the available study information
Generally, clinical trials for advanced solid cancers (tumors that have grown or spread in organs or tissues) may exclude patients based on certain health conditions, previous treatments, or other factors, but these specific details are not available in this case
If you are interested in this study, the research team would need to provide the complete list of reasons that would prevent participation

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain
Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain
Katholisches Klinikum Bochum gGmbH
Responsive
Bochum, Germany

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Investigated drugs

BNT329 is an investigational medication being studied in this trial. It is designed to target cancer cells that express a specific marker called CA19-9, which is found in certain types of advanced solid tumors. This is an experimental treatment being tested to see if it is safe and if it can help fight cancer by specifically attacking tumor cells that have this marker on their surface.

What is already known about the treatment

BNT329 – BNT329 is an experimental cancer treatment currently being studied in early-phase clinical trials for advanced solid tumors that produce a protein marker called CA19-9. This medication is administered to patients with cancers that have spread or progressed, and researchers are testing it to determine safe dosing levels and whether it can help shrink tumors. The drug works by targeting the CA19-9 protein, which is found on the surface of certain cancer cells, allowing the immune system or the medication itself to attack these specific cancer cells more effectively. BNT329 belongs to a class of targeted cancer therapies designed to recognize and bind to specific markers on tumor cells, distinguishing them from normal healthy cells in the body.

Investigated diseases

Advanced Solid Cancers – Advanced solid cancers refer to malignant tumors that have grown beyond their original location in the body. These cancers develop from solid tissues such as organs and can spread to nearby tissues or distant parts of the body through a process called metastasis. The term "advanced" indicates that the cancer has progressed to a later stage, meaning it may have grown larger, spread to lymph nodes, or reached other organs. Solid cancers can originate in various parts of the body including the lungs, breast, colon, pancreas, and many other organs. As these cancers progress, they continue to grow and may interfere with the normal function of affected organs and tissues. The progression of advanced solid cancers varies depending on the type of cancer, its location, and individual patient factors.