Unknown Cancer NIHR-supported project Diabetes, Hormones & Metabolism

A Master protocol, Open Label, Phase 2a Study of AZD0901 as Monotherapy or in Combination with Anti-cancer Agents in Participants with advanced or metastatic solid tumors expressing Claudin 18.2

In plain English

AI plain-English summary

A drug designed to seek out and destroy tumour cells carrying a specific protein is being tested in people with advanced stomach, gullet, or pancreatic cancers that cannot be removed by surgery. Current chemotherapy and immunotherapy often fail to shrink these cancers or keep them under control for long. Many of these tumours carry high levels of a protein called CLDN18.2 on their cell surfaces. The trial drug, AZD0901, is engineered to recognise that protein and kill the cells that display it. Researchers want to find out whether AZD0901—given alone or alongside other chemotherapy drugs—causes fewer side effects and works better than standard treatments. If the drug proves effective, it could offer a new, more targeted option for patients whose cancers currently have few good alternatives. The trial is recruiting adults whose tumours are CLDN18.2-positive, and participants receive the drug through a drip into a vein.

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 usually not successful enough in shrinking or controlling cancer for long. As a result, researchers are looking for treatments which might be better than the current available treatments. Some solid tumours have cells that have a certain protein called CLDN18.2. When tumours have a lot of cells that have CLDN18.2, they are called CLDN18.2-positive. The trial drug, AZD0901, is designed to find tumour cells that have CLDN18.2 on them and kill them. In this trial, researchers want to learn more about the trial drug AZD0901. Researchers want to learn about the side effects of AZD0901 and want to find out if AZD0901 could work better than standard cancer treatments for adults with advanced solid tumours that are CLDN18.2-positive.This trial currently has 2 sub-trials. In Sub-trial 1, participants with stomach cancer will receive different doses of AZD0901 alone. In Sub-trial 2, participants with pancreatic cancer will receive AZD0901 along with one or more chemotherapy drugs.AstraZeneca is the sponsor of this trial, and patients will be recruited from the US, Canada, Japan, Taiwan, Australia, Moldova, Georgia, UK, Malaysia, Singapore, Poland, Spain and South Korea. This trial will include up to 390 participants. 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.AZD0901 will be administered through a needle into a vein (intravenous infusion, also called IV infusion).

Researchers

Alexa Childs (Principal Investigator)

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