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Sonesitatug Vedotin for Advanced Gastric, GEJ, or Esophageal Adenocarcinoma

This study is testing new combinations of medicines for advanced or metastatic stomach (gastric), gastroesophageal junction (GEJ), or esophageal adenocarcinoma that has not been treated before. You might be eligible if your cancer has specific markers called Claudin18.2 (CLDN18.2) positive and HER2-negative. The study will look at how well Sonesitatug vedotin, Capecitabine, and Rilvegostomig work together, and if they are safe. Researchers will measure how long people live and how long they live without their cancer growing or spreading. This study plans to enroll 2130 participants.

Study design
This study is an interventional study with a planned enrollment of 2130 participants. It includes two groups (cohorts) based on specific biomarkers.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 5 years to measure how long they live and how long they live without their cancer growing or spreading.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07431281

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~2,130 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Sonesitatug vedotinRilvegostomigNivolumabCapecitabine5-FluorouracilOxaliplatin

At a glance

Recruiting sites
57 of 286 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) (Cohort 1 and Cohort 2)
Measured over Up to approximately 5 years
+1 more outcome measured

Conditions

Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Esophageal Cancer

Explore related trials

Esophageal CarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaClaudin-18 Isoform A2Programmed Cell Death 1 Ligand 1

Where it's being run

286 sites across 59 states
China43
Germany23
Japan18
India11
Brazil8
Hungary8
South Korea8
Taiwan8

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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:
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

What this trial measures

  • Progression Free Survival (PFS) (Cohort 1 and Cohort 2)Up to approximately 5 years

    PFS is defined as time from randomisation until progression per RECIST 1.1, or death due to any cause, whichever occurs first.

  • Overall Survival (OS) (Cohort 1)Up to approximately 5 years

    OS is defined as the time from randomisation until the date of death due to any cause.