Recipient organisationNIHR Royal Liverpool & Broadgreen University Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodMar 2025 — Ongoing
In plain English
AI plain-English summary
A new drug, AZD5863, is being tested for the first time in humans to see if it can help the immune system shrink advanced stomach, gullet, or pancreatic cancers that cannot be removed by surgery. Current chemotherapy and immunotherapy often fail to control these cancers for long. This matters because patients with these advanced solid tumours have few effective treatment options, and survival rates remain poor. The drug targets a protein called CLDN18.2, which is found on the surface of many of these tumour cells, aiming to direct the immune system to attack them more precisely. If the trial succeeds, it could offer a new treatment pathway for patients who currently run out of options. The research is structured in two modules: one delivers the drug intravenously, the other as a subcutaneous injection. Up to 200 participants across eight countries, including the UK, will be enrolled. The trial first finds the safest and most effective dose, then tests how well that dose controls tumour growth in a larger group. A positive result would not change daily life for most people, but it could extend survival for a specific group of cancer patients with few alternatives.
View original technical description
When a patient has advanced or metastatic gastric (stomach), oesophageal (gullet) or pancreas cancer, this means that surgery will not be possible to remove the cancer. Instead, chemotherapy or chemotherapy plus immunotherapy is recommended, dependent on the cancer type. However, current treatments are not usually successful in shrinking or controlling cancer for long. As a result, researchers are looking for treatments which might be better than the current available treatments. The trial drug, AZD5863, is designed to help the immune system fight cancer. This is a first-in-human trial, which means that this will be the first time that anyone has received AZD5863. In this trial, the researchers want to learn more about how AZD5863 affects people with advanced or metastatic solid tumours.This trial has 2 modules which each has 2 parts. In Part A of each module, the researchers will increase the dose of the trial drug for each group of participants until they find the best dose or doses for Part B of each module. In Part B of each module, the researchers will look at how well the best dose(s) work(s) for more participants. The best dose is determined based on the results of side effects and whether the drug has resulted in tumour shrinkage.AstraZeneca is the sponsor of this trial, and patients will be recruited from UK, China, France, Japan, Netherlands, South Korea, Taiwan and USA. The first 2 modules of this trial will include up to 200 participants, depending on how many doses are studied. All participants in this trial will be 18 years of age or older and have advanced or metastatic gastric, oesophageal or pancreatic cancer. Participants’ tumours must express CLDN18.2.In Module 1 the trial drug, AZD5863 will be administered through a needle into a vein (intravenous infusion, also called IV infusion). In Module 2, AZD5863 will be administered through a needle under the skin (subcutaneous injection).
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