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Taking people in CanadaPhase 3

Sonesitatug vedotin with capecitabine for advanced stomach and esophageal cancer

Tests sonesitatug vedotin with capecitabine in adults with advanced stomach or esophageal cancer.

Key facts

Who runs it
AstraZeneca
Where
Abbotsford British Columbia, Barrie, Brampton, Edmonton, Moncton, Montreal, Ottawa, Québec, Sault Ste. Marie, Toronto, Vancouver, and Winnipeg, CanadaSee the 12 sitesAlso in 23 other countries, 259 sites
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
2,130 people, planned
Started
3 Feb 2026
Expected to end
27 Oct 2031
Type of study
Interventional, 5 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Sonesitatug vedotin
  • Rilvegostomig
  • Nivolumab
  • Capecitabine
  • 5-Fluorouracil
  • Oxaliplatin
  • Zolbetuximab
  • Leucovorin
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with gastric, gastroesophageal junction or lower esophageal adenocarcinoma that has not been treated before, cannot be removed by surgery or has spread, and is Claudin18.2-positive and HER2-negative.

Age
18 years or older (or the legal age of consent where the study takes place)
Sex
All sexes
Disease stage
Adenocarcinoma of the stomach, gastroesophageal junction or distal third of the esophagus that cannot be removed by surgery, is locally advanced or has spread. At least one lesion that can be assessed by the investigator (RECIST 1.1).
Earlier treatment
No earlier treatment for this cancer.
Biomarker or test result
Claudin18.2-positive, tested centrally. PD-L1 status is also tested centrally and decides the cohort. HER2-positive people cannot join.

Main reasons for not taking part

  • Known HER2-positive cancer
  • Unstable stomach bleeding or untreated stomach ulcers
  • Autoimmune or inflammatory disease needing steroids or other immune-suppressing treatment
  • Fluid in the lungs or belly that needs drainage
  • Known partial or total DPD enzyme deficiency

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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:; Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement; 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

Who cannot take part

  • 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
  • Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline
  • Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation
  • Significant or unstable gastric bleeding and/or untreated gastric ulcers
  • Cardiac abnormalities as outlined in the protocol
  • 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 HER2-positive status
  • 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
  • Known partial or total DPD enzyme deficiency

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Have you had medicine for the cancer (such as chemotherapy) since it was found that it cannot be removed by surgery or has spread?
  • Has your doctor told you that the cancer cannot be removed by surgery, or that it has spread to other parts of the body?
  • Has a test of your tumour shown that it is HER2-positive?

Where in Canada

Also in 23 other countries, 259 sites

  • Abbotsford British Columbia, British ColumbiaHospital not named in the registryTaking people
  • Barrie, OntarioHospital not named in the registryTaking people
  • Brampton, OntarioHospital not named in the registryTaking people
  • Edmonton, AlbertaHospital not named in the registryNot yet recruiting
  • Moncton, New BrunswickHospital not named in the registryTaking people
  • Montreal, QuebecHospital not named in the registryTaking people
  • Ottawa, OntarioHospital not named in the registryTaking people
  • Québec, QuebecHospital not named in the registryTaking people
  • Sault Ste. Marie, OntarioHospital not named in the registryTaking people
  • Toronto, OntarioHospital not named in the registryTaking people
  • Vancouver, British ColumbiaHospital not named in the registryNot yet recruiting
  • Winnipeg, ManitobaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The 5 groups in the trial

  • Arm ATreatment being tested

    Sonesitatug vedotin + Rilvegostomig + Capecitabine

    Treatment: Sonesitatug vedotin, Rilvegostomig, and Capecitabine

  • Arm BTreatment being tested

    Sonesitatug vedotin + Nivolumab + Capecitabine

    Treatment: Sonesitatug vedotin, Nivolumab, and Capecitabine

  • Arm CExisting treatment, for comparison

    Nivolumab + CAPOX OR Nivolumab + FOLFOX * nivolumab, capecitabine, oxaliplatin * nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin

    Treatment: Nivolumab, Capecitabine, 5-Fluorouracil, Oxaliplatin, and Leucovorin

  • Arm DTreatment being tested

    Sonesitatug vedotin + Capecitabine

    Treatment: Sonesitatug vedotin and Capecitabine

  • Arm EExisting treatment, for comparison

    Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX: * zolbetuximab, capecitabine, oxaliplatin * zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin CAPOX or FOLFOX: * oxaliplatin, capecitabine, * 5-Fluorouracil, leucovorin, oxaliplatin

    Treatment: Capecitabine, 5-Fluorouracil, Oxaliplatin, Zolbetuximab, and Leucovorin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
Plain-language title
Sonesitatug vedotin with capecitabine for advanced stomach and esophageal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07431281, who can take part
Record updated
16 October 2026