AZD0901 in participants with advanced solid tumours expressing Claudin 18.2.
Research type
Research Study
Full title
A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Tumours Expressing Claudin 18.2.
IRAS ID
1008977
Contact name
Ghada Chaabani
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
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).REC name
North East - York Research Ethics Committee
REC reference
24/NE/0017
Date of REC Opinion
13 Mar 2024
REC opinion
Further Information Unfavourable Opinion