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Study on the Effectiveness and Safety of AZD0901 Compared to Standard Treatments for Adults with Advanced Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2

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What is this trial about?

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

This clinical trial is focused on studying the effectiveness and safety of a new treatment called AZD0901 for adults with advanced or metastatic gastric cancer and gastroesophageal junction cancer. These types of cancer are characterized by high levels of a protein known as Claudin 18.2. The trial aims to compare AZD0901 with standard cancer treatments chosen by the doctors involved in the study.

The study will involve participants receiving either AZD0901 or one of the standard treatments, which may include medications like Docetaxel, Irinotecan, Paclitaxel, Lonsurf (which contains trifluridine and tipiracil), or Cyramza (which contains ramucirumab). These treatments are typically administered as solutions for infusion, meaning they are given directly into the bloodstream through a vein, except for Lonsurf, which is taken as a tablet by mouth.

The purpose of the study is to determine if AZD0901 is more effective than the standard treatments in improving the health outcomes of participants. The trial will be conducted over several years, and participants will be monitored closely to assess the treatment's impact on their cancer and overall health. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied. The study will help researchers understand how well AZD0901 works and its safety profile compared to existing cancer therapies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

    The study focuses on individuals with advanced or metastatic gastric or gastroesophageal junction cancers expressing a protein called CLDN18.2.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the experimental drug AZD0901 or a standard treatment chosen by the investigator.

    This process ensures that the study results are unbiased and reliable.

  3. Step 3

    Treatment administration

    If assigned to the AZD0901 group, the medication is administered intravenously. The frequency and dosage are determined by the study protocol.

    If assigned to the standard treatment group, options may include medications such as docetaxel, irinotecan hydrochloride trihydrate, trifluridine, tipiracil, ramucirumab, or paclitaxel. These are also administered intravenously, except for trifluridine, tipiracil, which is taken orally.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    Assessments include measuring the progression of the disease and overall survival rates.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up visits are scheduled to continue monitoring health status and any long-term effects of the treatment.

    The study aims to conclude by October 2026, with ongoing assessments throughout the trial period.

Who can join the trial?

11 criteria

  • Participant must be at least 18 years old or the legal age of consent in their area.
  • Must have a type of cancer called **adenocarcinoma** that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body. This includes cancer of the stomach, the area where the stomach meets the esophagus, or the lower part of the esophagus.
  • The cancer must show positive **CLDN 18.2 expression**, which is a specific protein found in some cancer cells, confirmed by a central lab.
  • If the participant has had treatments targeting **CLDN18.2** before, a new sample of the cancer must be provided for testing if the cancer has progressed.
  • The cancer must have gotten worse after at least one previous treatment for advanced or spread cancer, which included specific drugs called a **fluoropyrimidine** and a **platinum**.
  • Must have at least one area of cancer that can be measured or evaluated by the study doctor using a standard method called **RECIST 1.1**.
  • Must have an **ECOG performance status** of 0 or 1, which means the participant is fully active or has some symptoms but can still do light work, with no worsening in the last 2 weeks before starting the study.
  • Must have a predicted life expectancy of at least 12 weeks.
  • Must have adequate function of organs and bone marrow, which are parts of the body that make blood cells.
  • Must weigh at least 35 kg (about 77 pounds).
  • Must meet specific requirements related to sex and use of birth control.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer than the ones being studied, such as **gastric cancer** or **gastroesophageal junction adenocarcinoma**.
  • Patients who do not have cancer that expresses **Claudin18.2**, a specific protein found in some cancer cells.
  • Patients who are not in the age range specified for the study.
  • Patients who are not in the specific group of people the study is looking to include.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

  • AZD0901

    is an investigational medication being studied for its potential to treat advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. It is being tested to see if it can improve progression-free survival (PFS) and overall survival (OS) in patients who have already received other treatments. This medication targets a specific protein called Claudin 18.2, which is found in certain cancer cells, and aims to stop the cancer from growing or spreading.

  • Investigator's Choice of Therapy

    refers to a selection of standard treatments that the doctor can choose from for the patient. These treatments are already approved and commonly used for treating advanced gastric or gastroesophageal junction adenocarcinoma. The choice depends on the patient's previous treatments and overall health. The study compares the effectiveness of AZD0901 against these standard treatment options to see which works better for patients.

What is already known about the treatment

AZD0901 – This medication is administered as a monotherapy for patients with advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma expressing Claudin 18.2. Currently, it is being evaluated in a Phase III clinical trial to determine its effectiveness compared to other therapies chosen by investigators. The main therapeutic indication is for second- or later-line treatment in adults with these specific types of cancer. AZD0901 works by targeting the Claudin 18.2 protein, which is often overexpressed in these cancers, potentially inhibiting tumor growth. It is classified as a targeted cancer therapy, focusing on specific molecular markers within cancer cells.

Investigated diseases

  • Gastric Cancer

    Gastric cancer is a disease where malignant cells form in the lining of the stomach. It often begins in the mucus-producing cells on the inside of the stomach and can grow slowly over many years. As it progresses, the cancer may invade deeper layers of the stomach wall and spread to nearby organs or lymph nodes. Symptoms can include indigestion, stomach pain, nausea, and weight loss. The disease can be influenced by factors such as diet, smoking, and infections like Helicobacter pylori.

  • Advanced/Metastatic Gastric Cancer

    This form of gastric cancer has spread beyond the stomach to other parts of the body. It is characterized by the cancer cells invading distant organs, such as the liver, lungs, or peritoneum. Symptoms may become more severe and include difficulty swallowing, vomiting, and significant weight loss. The progression of the disease can lead to complications like bleeding or obstruction in the stomach. It often requires more intensive management due to its widespread nature.

  • Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

    This is a specific type of cancer located where the stomach meets the esophagus, characterized by the expression of the protein Claudin18.2. It typically arises from glandular cells and can affect the lower esophagus and upper stomach. The disease may cause symptoms such as heartburn, difficulty swallowing, and chest pain. As it progresses, it can invade nearby tissues and spread to distant organs. The presence of Claudin18.2 can influence the behavior and treatment approach of the cancer.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508276-11-00Protocol codeD9802C00001Estimated enrolment572 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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