Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

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

2,130 Participants
are divided into 5 treatment groups

Locations

286
Australia
Research Site2010, Darlinghurst Australia
Research Site2605, Garran Australia
Research Site3084, Heidelberg Australia
Research Site6150, Murdoch Australia

Sponsors and collaborators

AstraZeneca

Lead sponsor