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Study of rilvegostomig, trastuzumab deruxtecan, and AZD0901 in patients with locally advanced resectable gastroesophageal cancer before and after surgery

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study focuses on treating patients with locally advanced resectable gastroesophageal adenocarcinoma, which is a type of cancer affecting the stomach and the area where the stomach connects to the esophagus (food pipe). The study will test three experimental medications: Rilvegostomig (also known as AZD2936), trastuzumab deruxtecan (also known as DS-8201a), and AZD0901. These medications will be given through an infusion, which means they will be administered directly into a vein.

The purpose of this research is to evaluate how safe these medications are and how well patients tolerate them when given before and after surgery. The study will also look at how effective the treatments are at fighting the cancer before surgery is performed. During the study, patients will receive the study medications, undergo surgery to remove the cancer, and then continue with additional treatment after surgery.

This is an open-label study, which means both doctors and patients will know which medication is being given. The study will include multiple treatment groups testing different combinations of these medications. Patients will be assigned to specific treatment groups based on certain characteristics of their cancer, including whether their cancer cells have specific markers called CLDN18.2 or HER2.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    Your eligibility for the study will be evaluated based on specific criteria, including age (18-75 years), diagnosis of gastroesophageal adenocarcinoma (cancer of the stomach or esophagus), and confirmation that your cancer is resectable (can be surgically removed)

    Your tumor will be tested to determine if it is CLDN18.2 positive and HER2 negative (for Substudy 1) or HER2 positive (for Substudy 2)

    Your overall health status will be evaluated using the ECOG scale (a measure of daily living abilities), which must be 0 or 1

    Your organ function and body weight (must be above 35 kg) will be assessed

  2. Step 2

    Treatment before surgery (neoadjuvant phase)

    You will receive treatment through infusion (medication delivered directly into your vein) with one or more of these medicines: Rilvegostomig, DS-8201a, or AZD0901

    Your response to the treatment will be monitored through regular medical assessments

    The medical team will track any side effects or reactions to the treatment

  3. Step 3

    Surgery phase

    Surgery will be performed to remove the tumor

    The removed tissue will be examined to measure how well the pre-surgery treatment worked

    The success of the treatment will be determined by checking if any viable cancer cells remain in the removed tissue

  4. Step 4

    Monitoring and follow-up

    Regular check-ups will continue to monitor your recovery and health status

    Your medical team will track any side effects through laboratory tests, vital signs measurements, and heart monitoring (ECG)

    The study will continue until January 31, 2029

Who can join the trial?

6 criteria

  • Age between 18 and 75 years old at the time of signing the consent form
  • Confirmed diagnosis of gastric, GEJ, or esophageal adenocarcinoma (cancer of the stomach or the area where the stomach and esophagus meet) that can be surgically removed
  • Must test positive for CLDN18.2 (a protein marker) and negative for HER2 (Substudy 1) or positive for HER2 (Substudy 2)
  • ECOG score of 0 or 1 (meaning patient must be able to perform all or most daily activities independently)
  • Normal functioning of major organs and adequate bone marrow function (based on blood test results)
  • Body weight must be more than 35 kilograms

Who cannot join the trial?

13 criteria

  • Patients younger than 18 years or older than 75 years of age
  • Patients with metastatic disease (cancer that has spread to distant parts of the body)
  • Patients with previous chemotherapy or radiation therapy for gastroesophageal cancer
  • Patients with serious heart conditions including uncontrolled hypertension (high blood pressure) or recent heart attack
  • Pregnant or breastfeeding women
  • Patients with active infections requiring treatment
  • Patients with known allergies to the study medications
  • Patients with significant liver or kidney problems
  • Patients with other types of cancer in the past 5 years (except for adequately treated non-melanoma skin cancer)
  • Patients unable to swallow medications
  • Patients with severe mental health conditions that could interfere with study compliance
  • Patients participating in other clinical trials within 30 days before starting this study
  • Patients with conditions that would make surgery too risky
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Investigated drugs

  • AZD0901

    is an experimental drug being tested in the study. It is given by infusion and is intended to see if it can be safely used before surgery for patients with locally advanced gastroesophageal cancer. Researchers will watch for side effects and will check whether the tumor shrinks or shows signs of response after the drug is given.

  • Rilvegostomig

    is another investigational agent evaluated in the trial. Like the other drug, it is administered through an infusion before the tumor is surgically removed. The study will monitor how well patients tolerate it, any safety concerns, and whether it helps reduce the size or activity of the cancer before surgery.

  • Trastuzumab deruxtecan

    (also known as DS‑8201a) is a targeted therapy that combines an antibody with a chemotherapy payload. In this trial it is given by infusion before the operation to treat gastroesophageal adenocarcinoma that expresses the HER2 protein. The trial will assess its safety, how the body processes the drug, and whether it improves the pathological response of the tumor when surgery follows.

What is already known about the treatment

  • AZD0901

    This drug is given as an infusion solution that is delivered directly into a vein. It is still an experimental compound and is being studied in early clinical trials, so it is not yet approved for routine medical use. The drug is being tested for treating locally advanced gastroesophageal cancer by blocking a signaling pathway that helps tumors grow. It belongs to the class of targeted therapy agents that aim at specific molecules involved in cancer growth.

  • Rilvegostomig

    This medication is also administered as an intravenous infusion of a sterile solution. It is a new investigational drug that has not yet received regulatory approval and is currently only available within clinical studies. Researchers are evaluating it for use in gastroesophageal adenocarcinoma, where it is thought to interfere with tumor cell communication signals. Rilvegostomig is classified as an experimental targeted therapy under investigation.

  • Trastuzumab deruxtecan

    This treatment is given by infusion into a vein as a sterile solution. It is an approved medication in several countries for HER2‑positive cancers and is widely described in medical literature. The drug works by attaching a chemotherapy payload to an antibody that seeks out HER2 proteins on cancer cells, delivering the poison directly to the tumor while sparing most normal cells. It is classified as an antibody‑drug conjugate, a type of targeted cancer therapy.

Investigated diseases

Gastroesophageal Adenocarcinoma - A cancer that begins in the glandular cells at the junction where the esophagus meets the stomach. The cancer develops when normal cells in the gastroesophageal junction begin to grow and multiply uncontrollably, forming a tumor. The disease typically starts in the inner layer of the gastroesophageal tissue and can grow through the wall of the esophagus or stomach. This condition can cause difficulty swallowing, heartburn, and discomfort in the upper abdomen. The disease may progress from a localized (resectable) stage, where the tumor is confined to a specific area, to more advanced stages if left untreated.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516909-23-00Protocol codeD9804C00001Estimated enrolment219 patientsSponsorAstraZeneca AB

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