About this trial
The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
Eligibility criteria
Qualifiers
Capable of giving signed informed consent
Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
Positive CLDN18.2 expression, as determined prospectively by central IHC testing
Disqualifiers
Known HER2-positive status
Significant or unstable gastric bleeding and/or untreated gastric ulcers.
Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.
CNS pathology
Trial design
Treatments tested in this trial
- Sonesitatug vedotin
- Rilvegostomig
- Nivolumab
- Capecitabine
- 5-Fluorouracil
- Oxaliplatin
- Zolbetuximab
- Leucovorin
Treatment groups
Locations
286Sponsors and collaborators
AstraZeneca
Lead sponsor