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 (CLARITY-Gastric 01)

Research summary

This Phase III, multi-center, open-label, sponsor-blinded, randomized study is designed to evaluate the efficacy and safety of AZD0901 compared to Investigator’s choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2, and the clinical performance of the investigational IVD. As part of this combined approach, t he efficacy analyses from this study will also provide the basis to evaluate the clinical performance of Ventana CLDN18.2 (SP455) IHC assay (prototype assay and/or validated assay or an alternative central test as required) as an IVD device for the identification of patients with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2 who may benefit from AZD0901.

Principal Investigator

Dr Elizabeth Smyth

Contact us

Email: orh-tr.earlyphasenurses@nhs.net

IRAS number

1009237