In short
Clinical trials are investigating AZD4360 in adults with advanced solid tumors, including certain stomach, bile duct, and pancreatic cancers. The studies aim to learn about safety, how well AZD4360 works, and how it moves through the body. They also look for a dose that can be used in later studies.
Key points
- AZD4360 is being studied in a Phase 1/2 clinical trial in adults with advanced solid tumors. The trial includes gastric cancer, gastroesophageal junction cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma. It focuses on safety, tolerability, early signs of how well the treatment works, and how the body processes the treatment. The study also looks for dose-limiting toxicities, adverse events, and changes in vital signs, lab tests, and ECG results. The participants are previously treated adults whose tumors show CLDN18.2 expression. One authorised trial is listed, with an enrollment of 141 people.
Trial overview
The trial NCT06921928 is studying AZD4360 in adults with advanced solid tumors, which means solid cancers that have grown or spread. It is an interventional study, so participants receive the study treatment as part of the research.
The study is authorised and plans to include 141 participants. It is looking at safety, tolerability, early activity, and how AZD4360 moves through the body over time.
Who can participate
This study is for adults who have previously been treated and now have advanced solid tumors. The trial also requires CLDN18.2 expression, which means the cancer cells must show this marker.
The listed cancer types are gastric cancer, gastroesophageal junction cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma. In simple terms, the study is looking for people with certain advanced cancers who still have this marker on their tumor cells.
What the trial measures
The main safety measure is the frequency of dose-limiting toxicities in the dose-escalation part of the study. Dose-limiting toxicities are side effects that are serious enough to stop the dose from being increased.
The study also measures adverse events, serious adverse events, and adverse events that lead to stopping AZD4360. Adverse events are unwanted medical problems that happen during a study, whether or not the treatment caused them.
In addition, the trial checks for clinically important changes in vital signs, laboratory tests, and ECG results. An ECG is a test that records the heart's electrical activity.
Study phase and design
This is a Phase 1/2 trial. Phase 1 studies usually focus on safety and dose, while Phase 2 studies look more closely at whether the treatment may help.
The brief summary says the study aims to find the Maximum Tolerated Dose and/or a Recommended Phase 2 Dose of AZD4360. These are the doses chosen after early testing so later studies can use a dose that is more likely to be suitable.
AZD4360 is given by intravenous use, which means it is administered through a vein.
Conditions being studied
The trial includes several cancer types, but all of them are advanced solid tumors. The specific conditions are gastric cancer, gastroesophageal junction cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma.
These are serious cancers that may need new treatment options, which is why early-stage clinical research is important. The study is especially focused on tumors with CLDN18.2 expression.
Why this trial matters
This trial is an early step in learning whether AZD4360 can be studied further in people with advanced cancers. It is designed to answer practical research questions first, such as safety, dose, and early signs of benefit.
Because it includes previously treated adults, the study is looking at a population that has already had cancer therapy and still needs more options. The results may help decide whether AZD4360 should move into later clinical testing.