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Study of AZD0901 (sonesitatug vedotin) with capecitabine ± rilvegostomig in adults with advanced stomach or esophageal cancer (Claudin‑18.2‑positive, HER2‑negative)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on adults with advanced or metastatic gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal cancer that shows a protein called Claudin18.2-positive and does not have the HER2 protein (HER2-negative). The experimental treatment combines an antibody‑drug conjugate named sonesitatug vedotin with a chemotherapy pill called capecitabine. In one group the combination also includes an intravenous medication known as rilvegostomig. All medicines are given through a vein (IV) in a clinic.

The main aim of the study is to see whether this new regimen works better and is safe compared with the usual care for these cancers.

Participants will receive the study medicines in repeated treatment cycles, each lasting a few weeks, with regular check‑ups to monitor tumor size and overall health. Tumor changes are measured using standard imaging and a set of rules called RECIST 1.1. The study looks at how long patients live without the cancer getting worse, known as PFS, and how long patients live overall, referred to as OS. Blood tests and heart checks are done throughout to watch for side effects.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study enrolment and assignment

    Upon joining the study you are assigned to a treatment group that will determine which medicines you receive during the trial.

  2. Step 2

    First infusion of <b>sonesitatug vedotin</b>

    You receive sonesitatug vedotin by intravenous infusion, meaning the medicine is delivered into a vein through a needle.

    The exact amount of the drug and how often it is given are defined in the study protocol.

  3. Step 3

    Starting oral <b>capecitabine</b> therapy

    You take capecitabine tablets by mouth according to the schedule written in the protocol.

    The dose and frequency are specified by the study investigators.

  4. Step 4

    Optional infusion of <b>rilvegostomig</b>

    If your assigned group includes rilvegostomig, you receive this medicine by intravenous infusion.

    The dose and timing follow the study protocol.

  5. Step 5

    Repeating treatment cycles

    The infusion of sonesitatug vedotin, the oral intake of capecitabine, and, when applicable, the infusion of rilvegostomig are repeated in a series of cycles.

    Each cycle follows the schedule described in the protocol and continues until the end of the planned treatment period, disease progression, or unacceptable side effects.

  6. Step 6

    Regular follow‑up visits

    Throughout the trial you attend scheduled clinic visits where health professionals check vital signs, perform laboratory tests, and evaluate disease status.

    These visits are used to monitor safety and how well the treatment works.

  7. Step 7

    Completion of study participation

    The trial ends for you when the treatment period is finished, the disease progresses, or a safety concern requires stopping the medication.

    After completion you may continue to be followed for additional safety assessments as described in the study protocol.

Who can join the trial?

12 criteria

  • Be able to sign a consent form that shows you understand the study (informed consent).
  • Weigh at least 35 kg (about 77 lb).
  • Follow the study’s rules about sex and use of birth control (contraceptive requirements).
  • Be at least 18 years old, or the legal adult age in your country, when you sign the consent.
  • Have a diagnosis of stomach, gastro‑esophageal junction, or lower esophagus cancer that cannot be removed by surgery and has spread locally or to other parts of the body, confirmed by a tissue test (histologically documented unresectable, locally advanced, or metastatic adenocarcinoma).
  • Have cancer cells that test positive for the protein CLDN18.2.
  • Have a PD‑L1 test result that determines which group you belong to:
    • Group 1: PD‑L1 score (CPS) of 1 or higher and the doctor decides you are eligible for immune‑targeted therapy (ICI).
    • Group 2: PD‑L1 score less than 1 or the doctor decides you are not eligible for ICI.
    • Have an ECOG performance status of 0 or 1 (fully active or able to do light work) and it has not gotten worse in the past two weeks.
    • Have a life expectancy of at least 12 weeks.
    • Have at least one tumor spot that doctors can measure or see clearly, using standard criteria called RECIST 1.1.
    • Have blood, liver, kidney and bone‑marrow test results that are within the safe ranges required by the study (adequate organ and bone marrow function).

Who cannot join the trial?

12 criteria

  • Known HER2‑positive status – the tumor has a protein called HER2; patients with this are not allowed.
  • Uncontrolled diabetes or diabetic nerve damage (neuropathy) within the last three months – high blood sugar that isn’t well‑managed or nerve problems caused by diabetes make you ineligible.
  • Active infections such as hepatitis A, uncontrolled hepatitis B, hepatitis C, or HIV that isn’t well‑controlled – having these viral infections, especially if they are active or not under treatment, excludes you.
  • Partial or total DPD enzyme deficiency – a lack of the enzyme DPD, which helps break down certain chemotherapy drugs, means you cannot join.
  • Significant or unstable stomach bleeding or untreated stomach ulcers – ongoing bleeding or open sores in the stomach prevent participation.
  • Autoimmune or inflammatory diseases that need steroid or other immune‑suppressing medicines – conditions where the immune system is over‑active and require strong medicines make you ineligible.
  • Problems in the brain or spinal cord (CNS pathology) – any disease affecting the central nervous system excludes you.
  • Large fluid collections in the chest (pleural effusion) or abdomen (ascites) that need drainage or a tube – having these fluid problems that require medical devices disqualifies you.
  • Need for feeding through a vein (parenteral nutrition) because of a stomach or intestinal blockage – if you cannot eat normally due to a blockage and need tube feeding, you cannot join.
  • Peripheral nerve damage (peripheral neuropathy) of moderate or greater severity (CTCAE Grade 2 or higher) – nerve problems that cause noticeable pain, tingling, or weakness at this level exclude you.
  • Ongoing side effects from previous cancer treatment that have not improved to mild (Grade 1) or less, except hair loss – lingering toxic effects that are still moderate or severe keep you out.
  • Heart problems as described in the study protocol – any significant heart abnormality listed in the trial rules makes you ineligible.
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Investigated drugs

  • sonesitatug vedotin

    is an experimental drug that combines an antibody with a chemotherapy agent. It is given through an IV and is designed to find and attach to cancer cells that have a special protein, then release the chemotherapy directly onto those cells. In this study it is being tested to see if it works better than the current standard treatments.

  • capecitabine

    is an oral chemotherapy pill that the body changes into a drug that stops cancer cells from growing. In the trial it is taken by mouth and is part of the treatment plan being compared to the usual care for advanced stomach and esophageal cancers.

  • rilvegostomig

    is a new drug given by IV infusion that works on the immune system to help the body fight cancer. It is being tested together with sonesitatug vedotin and capecitabine to see if the combination improves patients’ outcomes.

  • oxaliplatin

    is a chemotherapy medicine that is given by IV infusion. It is part of the standard chemotherapy regimens for stomach and esophageal cancers and is used in the trial as a reference treatment to compare the new drugs against.

  • folinic acid

    (also called calcium folinate) is a vitamin‑like substance given by IV infusion. It is used together with certain chemotherapy drugs to reduce side effects and help the chemotherapy work better. In the study it is part of the standard treatment arm.

  • fluorouracil

    is a chemotherapy drug given by IV infusion. It interferes with the cancer cells’ ability to make DNA, slowing their growth. It is a common component of standard therapy for stomach and esophageal cancers and serves as a comparator in this trial.

What is already known about the treatment

  • Oxaliplatin

    Oxaliplatin is given as a liquid that is injected into a vein (intravenous infusion). It is an established chemotherapy drug used for colorectal and stomach cancers and is well described in medical literature. It works by attaching to DNA in cancer cells, which stops the cells from copying their DNA and leads to cell death. It belongs to the class of platinum‑based antineoplastic agents.

  • Mycophenolate mofetil

    Mycophenolate mofetil comes in hard tablets taken by mouth. It is an approved medication for preventing organ transplant rejection and for certain autoimmune diseases, with many studies supporting its use. The drug blocks an enzyme needed for making DNA in immune cells, reducing their activity. It is classified as an immunosuppressant.

  • AZD0901

    AZD0901 is supplied as a liquid that is infused into a vein. It is an experimental drug that is still being investigated in early clinical trials and is not yet approved for routine use. The molecule is designed to block a specific growth‑factor receptor on cancer cells, which can slow tumor growth. It is categorized as a targeted therapy under investigation.

  • Infliximab

    Infliximab is provided as a powder that is mixed with liquid and given by intravenous infusion. It is an approved biologic used for inflammatory diseases such as Crohn’s disease and rheumatoid arthritis and has a long record in medical literature. The drug binds to a protein called tumor necrosis factor‑alpha (TNF‑α), preventing it from causing inflammation. It belongs to the class of monoclonal antibody anti‑TNF agents.

  • Nivolumab

    Nivolumab is a clear solution for injection that is administered through an IV infusion. It is an approved cancer immunotherapy used for several advanced cancers, with extensive clinical data supporting its effectiveness. The medication blocks the PD‑1 receptor on immune cells, allowing the body’s immune system to recognize and attack cancer cells. It is classified as a checkpoint inhibitor monoclonal antibody.

  • Folinic acid

    Folinic acid is supplied as a liquid injection given intravenously. It is an approved medication used to reduce side effects of certain chemotherapy drugs and to treat folate deficiency. The compound supplies a ready‑made form of folate that cancer cells cannot use, but normal cells can, helping protect healthy tissue. It is classified as a vitamin (folate) analogue.

Investigated diseases

  • Gastric cancer

    A malignant tumor that starts in the lining of the stomach. Abnormal cells grow and can form a mass that invades the stomach wall. Over time the tumor may spread to nearby lymph nodes. It can also extend beyond the stomach to other organs. The disease often progresses silently until it becomes larger.

  • Gastroesophageal junction adenocarcinoma

    Cancer that arises at the point where the esophagus meets the stomach. It begins in glandular cells of this junction and enlarges into a tumor. The growth can infiltrate surrounding tissues and involve nearby lymph nodes. As it advances, cancer cells may travel to distant parts of the body. The condition typically develops slowly at first and then accelerates.

  • Esophageal cancer expressing Claudin‑18.2

    A form of esophageal cancer whose cells display the protein Claudin‑18.2 on their surface. The tumor originates in the esophageal lining and expands into a mass. It can thicken the esophageal wall and narrow the passage for food. The disease may spread locally to surrounding structures and to distant sites. Progression often follows a pattern of gradual enlargement followed by faster invasion.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519787-40-00Protocol codeD9803C00001Estimated enrolment2 130 patientsSponsorAstraZeneca AB

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