Study on Sonesitatug Vedotin and Capecitabine, With or Without Rilvegostomig, for Advanced Stomach and Esophageal Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07431281

Provider View

This clinical trial is testing a new treatment combination for patients with advanced stomach, gastroesophageal junction, or esophageal cancer that is positive for Claudin18.2 and negative for HER2. The study aims to evaluate the safety and effectiveness of the drugs sonesitatug vedotin and capecitabine, with or without rilvegostomig.

Patient Parameters

Program Overview

The purpose of this study is to determine if a combination of the drugs sonesitatug vedotin and capecitabine, with or without rilvegostomig, can effectively treat advanced stomach, gastroesophageal junction, or esophageal cancer that is positive for Claudin18.2 and negative for HER2. The study will include two groups: one group will receive all three drugs if they are also positive for PD-L1, while the other group will receive sonesitatug vedotin and capecitabine if they are PD-L1 negative or not eligible for certain immune therapies.

Description

This Phase III study is designed to test the effectiveness and safety of a new treatment for advanced stomach and esophageal cancers that express Claudin18.2 and do not express HER2. The study involves two groups of participants. Group 1 will receive a combination of sonesitatug vedotin, capecitabine, and rilvegostomig if they are also positive for PD-L1. Group 2 will receive sonesitatug vedotin and capecitabine if they are PD-L1 negative or not eligible for immune checkpoint inhibitors. The study will assess how well these treatments work and their safety in patients.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent.
  • Must be 18 years or older.
  • Have advanced or metastatic stomach, gastroesophageal junction, or esophageal cancer that cannot be surgically removed.
  • Cancer must be positive for Claudin18.2.
  • Must have PD-L1 status confirmed and eligibility for immune therapy determined by the study doctor.
    • Group 1: PD-L1 positive and eligible for immune therapy.
    • Group 2: PD-L1 negative or not eligible for immune therapy.
  • Good overall health with a performance status of 0 or 1.
  • Expected to live at least 12 more weeks.
  • Have at least one tumor that can be measured.
  • Adequate organ and bone marrow function.
  • Weigh at least 35 kg.
  • Meet sex and contraceptive requirements.

Exclusion Criteria

  • Known to be HER2-positive.
  • Have significant or unstable stomach bleeding or untreated stomach ulcers.
  • Have active or past autoimmune or inflammatory disorders requiring treatment.
  • Have central nervous system issues.
  • Have significant fluid buildup in the chest or abdomen that requires drainage.
  • Require nutrition through a vein due to stomach or intestinal blockage.
  • Have nerve damage of grade 2 or higher.
  • Have unresolved side effects from previous cancer treatments.
  • Have heart problems as specified in the study.
  • Have uncontrolled diabetes or diabetic nerve damage.
  • Have active infections like hepatitis A, uncontrolled hepatitis B, hepatitis C, or uncontrolled HIV.
  • Have a deficiency in the DPD enzyme.

Locations

FACILITYZIPCITYSTATE
Research Site85054PhoenixArizona
Research Site72762SpringdaleArkansas
Research Site91010DuarteCalifornia
Research Site92835FullertonCalifornia
Research Site92093La JollaCalifornia
Research Site90720Los AlamitosCalifornia
Research Site92868OrangeCalifornia
Research Site94598Walnut CreekCalifornia
Research Site80210DenverColorado
Research Site80124Lone TreeColorado

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