At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sonesitatug vedotin (drug), Rilvegostomig (drug), Nivolumab (drug), Capecitabine (drug)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Sonesitatug vedotin — drug: Intravenous · Rilvegostomig — drug: Intravenous · Nivolumab — drug: Intravenous · Capecitabine — drug: Oral · 5-Fluorouracil — drug: Intravenous · Oxaliplatin — drug: Intravenous · Zolbetuximab — drug: Intravenous · Leucovorin — drug: Intravenous
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 2,130
- Started
- 2026-02-03
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for gastric cancer
- • Phase3 - 2,130 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with gastric cancer
Where?
- • Cambridge - Research Site
- • Dundee - Research Site
- • Leeds - Research Site
- • London - Research Site
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
The purpose of this Phase III study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in 1L CLDN18.2-positive, HER2-negative gastric, GEJ, and esophageal adenocarcinoma, and the clinical performance of the investigation in vitro diagnostics (IVDs). The study will include 2 cohorts to provide a treatment option for all participants that are HER2-negative and CLDN18.2-positive. Cohort 1 will evaluate sonesitatug vedotin in combination with rilvegostomig with capecitabine in participants who are CLDN18.2-positive and programmed death-ligand 1 (PD-L1) positive. Cohort 2 will evaluate sonesitatug vedotin in combination with capecitabine in participants who are CLDN18.2-positive and PD-L1 negative or immune checkpoint inhibitor (ICI) ineligible.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ to determine cohort eligibility as described below:
What the study is looking for
- ✓Capable of giving signed agreement to take part
- ✓Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at...
- ✓Previously untreated histologically documented unresectable, that has grown locally, or that has spread gastric, GEJ, or distal...
- ✓Positive CLDN18.2 expression, as determined prospectively by central IHC testing
- ✓Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to...
Who cannot take part
- ✗Known HER2-positive status
- ✗Significant or unstable gastric bleeding and/or untreated gastric ulcers.
- ✗CNS pathology
- ✗Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage,...
- ✗Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
See the full criteria
Where Is This Study? (6 UK sites)
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Dundee DD1 9SY, United Kingdom
Research Site
Leeds LS9 7TF, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Oxford OX3 7LE, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
