In short
BNT329 is an investigational drug being studied in people with advanced solid tumors that express the tumor marker CA19-9. There is currently one authorised clinical trial of BNT329, a Phase 1/2 study involving 245 participants. The trial is testing the safety, tolerability, and potential anti-tumor activity of BNT329 when given by intravenous infusion.
Key points
- BNT329 is being tested in a Phase 1/2 clinical trial for advanced solid tumors that express the tumor marker CA19-9.
- The trial is authorised and plans to enrol 245 participants.
- BNT329 is given as an intravenous infusion.
- The main goals are to assess safety and tolerability and to measure anti-tumor activity.
- Researchers will look at dose-limiting toxicities and treatment-emergent adverse events.
- In one part of the trial, researchers will measure the objective response rate.
What is BNT329?
BNT329 is an investigational drug. This means it has not yet been approved as a medicine. It is being studied in people with advanced solid tumors, which are cancers that form solid masses in organs or tissues, as opposed to cancers of the blood. The tumors being studied are known to express a tumor marker called CA19-9. CA19-9 is a protein that can be found on the surface of some cancer cells.
How does BNT329 work?
The available trial information does not describe the exact mechanism of action of BNT329. The trial is designed to test whether the drug is safe and potentially beneficial. The study will evaluate its anti-tumor activity according to RECIST 1.1, which is a standard way to measure whether tumors shrink, stay the same, or grow during treatment.
Which conditions is BNT329 being studied for?
- Advanced solid cancers that express the tumor marker CA19-9. These are cancers that have spread or cannot be removed by surgery and that test positive for the CA19-9 marker.
How is BNT329 given?
BNT329 is given as an intravenous infusion. This means the drug is delivered directly into a vein through a needle or catheter over a period of time.
What do the clinical trials show?
One clinical trial of BNT329 is currently authorised. It is a Phase 1/2 study, which means it combines the early testing of a Phase 1 trial, focused on safety and dosing, with the early effectiveness testing of a Phase 2 trial. The study plans to enrol 245 participants.
The trial has several parts. Parts A and B focus on safety and tolerability. They measure the occurrence of dose-limiting toxicities (DLTs), which are side effects severe enough to prevent increasing the dose. They also track treatment-emergent adverse events (TEAEs), which are any unwanted medical events that appear after treatment starts. These include serious adverse events (SAEs) and treatment-related side effects. Researchers also record any dose interruptions, reductions, or discontinuations of BNT329 due to side effects.
Part D of the trial evaluates anti-tumor activity. The main measurement here is the objective response rate (ORR). The ORR is the proportion of participants whose tumors show a confirmed complete response (CR), meaning the tumor disappears, or a partial response (PR), meaning the tumor shrinks significantly.
What side effects are known?
The trial is specifically designed to find out what side effects BNT329 may cause. At this stage, the side effects are not yet fully known. The study will carefully record all treatment-emergent adverse events, including serious ones, and any dose-limiting toxicities.