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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT07431281

View on ClinicalTrials.gov ↗

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.

Gastric CancerGastroesophageal Junction AdenocarcinomaEsophageal Cancer

How this trial compares with your answers

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What we know so far

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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

PD-L1L1 positiveL1 negativeHER2

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
Inclusion Criteria: * 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 * Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below: 1. Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement. 2. Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible * ECOG performance status of 0 or 1 with no deterioration to \> 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation. * Minimum life expectancy of ≥ 12 weeks. * At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1. * Adequate organ and bone marrow function as specified in the protocol * Body weight ≥ 35 kg. * Sex and contraceptive requirements Exclusion Criteria: * 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 * Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain. * Require parenteral nutrition support due to gastric or gastrointestinal obstruction. * Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening. * Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline. * Cardiac abnormalities as outlined in the protocol * Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation. * Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled * Known partial or total DPD enzyme deficiency

Where Is This Study? (6 UK sites)

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

Dundee DD1 9SY, United Kingdom

Recruiting

Research Site

Leeds LS9 7TF, United Kingdom

Recruiting

Research Site

London EC1A 7BE, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Oxford OX3 7LE, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09