A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
Recipient organisationNIHR Cambridge Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Oct 2026
In plain English
AI plain-English summary
A new experimental drug, AZD0901, is being tested against standard chemotherapy in a large international trial for people with advanced stomach or oesophageal cancers that carry a specific protein marker called CLDN18.2. This matters because these cancers are often diagnosed at a late stage, when surgery is no longer possible, and existing treatments have limited effectiveness. The drug is designed to home in on tumour cells displaying the CLDN18.2 protein and kill them directly, offering a more targeted approach than conventional chemotherapy. The trial compares AZD0901 against the best standard treatment chosen by each participant’s doctor, in patients who have already received at least one prior cancer therapy. If the drug proves more effective, it could provide a new, targeted treatment option for a subset of patients with these aggressive cancers—potentially improving survival and quality of life where current options have failed. The trial is recruiting from multiple countries, including the UK, and is sponsored by AstraZeneca.
View original technical description
Researchers are looking for a better way to treat advanced and metastatic gastric, gastroesophageal junction, or lower esophageal cancers. These cancers can have tumor cells that have a certain protein called CLDN18.2. When tumors have a lot of cells that have CLDN18.2, they are called CLDN18.2 positive. The trial drug, AZD0901, is designed to find tumor cells that have CLDN18.2 on them and kill them. Researchers think that AZD0901 could work better than standard cancer treatments for adults with advanced or metastatic gastric, gastroesophageal junction, or lower esophageal cancers that are CLDN18.2 positive and who have already had at least 1 cancer treatment. In this trial, some participants will receive AZD0901, and some will receive standard cancer treatments. The trial doctors will choose what they think is the best standard cancer treatment for each participant receiving it.This is a Phase 3, randomized, open-label, sponsor-blinded trial. Participants will receive treatment until it is no longer benefiting them, their cancer gets worse, they have to start a new cancer therapy, or they leave the trial for another reason.This trial will include up to about 625 participants. All participants will be 18 years of age or older and have CLDN18.2 positive advanced or metastatic gastric, gastroesophageal junction, or lower esophageal cancer that cannot be removed with surgery. Estimated treatment period is around 6 months per patient for all arms. Final database lock (DBL) is expected in year 2026. AstraZeneca is the sponsor of this study, and patients will be recruited from UK, Canada, France, Germany, Hong Kong, India, Italy, Poland, Spain, USA, Taiwan, South Korea, Japan, Turkey, Vietnam and China from sites experienced with gastric cancer clinical studies.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know