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