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RecruitingLast updated: 17 April 2026

CLARITY-Gastric02: Targeted therapy and chemotherapy, with or without immunotherapy, for people with advanced or metastatic stomach and oesophagus cancers that are CLDN18.2+ and HER2-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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

CLARITY-Gastric02

Clinical summary

Summary

This study is looking at how well and how safely a study medicine called sonesitatug vedotin works when it is given with capecitabine, with or without another medicine called rilvesgostomig. 

The study is for people receiving first-line treatment for certain stomach and oesophagus cancers. The cancers must be advanced or metastatic. This includes people whose cancer:

  • is CLDN18.2-positive
  • is HER2-negative
  • includes stomach (gastic), gastroesophageal junction (GEJ), or oesophageal cancer.

The study will also check how well the lab tests (diagnostic tests) work in identifying who may benefit from these treatments.

Study groups (cohorts)
The study has two groups, so that everyone who joins and meets the study eligibility criteria can receive a treatment option that is appropriate for them.

Cohort 1: Participants who are CLDN18.2-positive and PD-L1 positive will receive:

  • sonesitatug vedotin
  • capecitabine
  • rilvegostomig

Cohort 2: Participants who are CLDN18.2-positive and PD-L1 negative, or who are not able to receive immunotherapy, will receive:

  • sonesitatug vedotin
  • capecitabine

THe goal is to see how effective and safe these treatment combinations are for people with these specific cancer types.

Conditions

This trial is treating people with previously untreated unresectable, locally advanced or metastatic stomach, gastro-oesophageal junction or oesophageal cancers

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific 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

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