CLARITY-Gastric 01
Research type
Research Study
Full title
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)
IRAS ID
1009237
Contact name
Juliet Wou
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
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.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0218
Date of REC Opinion
26 Nov 2024
REC opinion
Further Information Favourable Opinion