Study of AZD0901 with drug combination as first‑line treatment for adults with advanced gastric or esophageal cancer

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What is this study about?

The trial involves adults whose cancer has spread and includes Gastric cancer, gastroesophageal junction adenocarcinoma or esophageal cancer that show the protein marker Claudin18.2-positive and lack the HER2 protein (HER2-negative). These cancers arise in the stomach or the area where the stomach meets the esophagus and are considered advanced when they have moved beyond the original site.

The purpose is to learn how well the experimental combination of sonesitatug vedotin with capecitabine and, in some participants, rilvegostomig works compared with the usual standard treatment. Participants receive intravenous infusions of the study drugs on a regular schedule and may also take oral capecitabine tablets; they are monitored with routine doctor visits, imaging scans, and laboratory tests to check for side effects and to see if the cancer is staying stable. Key outcomes include the length of time the disease does not get worse (progression‑free survival) and the overall length of survival, while safety is assessed by recording any adverse events.

1 baseline assessments

after joining the study, initial medical tests are performed. these include blood work, imaging scans, and review of medical history to confirm eligibility.

the results are used to assign the patient to a treatment group.

2 start of treatment – intravenous infusion

the first medication given is sonesitatug vedotin. it is administered by intravenous infusion. the exact dose, how often it is given, and how long treatment lasts are defined by the study protocol and continue until disease progression or unacceptable side effects.

3 oral chemotherapy

the patient also takes capecitabine tablets by mouth. the tablet strength is 150 mg. the specific dose per day, schedule (for example daily or on certain days), and total treatment period are determined by the study protocol.

4 optional additional infusion (cohort 1 only)

if assigned to cohort 1, the patient receives an additional intravenous infusion of rilvegostomig. the dose, frequency, and duration follow the study protocol and are continued until progression or toxicity.

5 regular monitoring visits

throughout the treatment period, the patient attends scheduled clinic visits. at each visit blood tests, safety assessments, and imaging scans are performed to monitor response and side effects.

any adverse events are recorded and managed according to the study guidelines.

6 treatment discontinuation and follow‑up

treatment stops when disease progression is documented, side effects become unacceptable, or the study ends.

after stopping treatment, the patient continues with follow‑up visits for additional assessments of survival and disease status.

Who Can Join the Study?

  • Must be able to give a signed informed consent, meaning you understand the study and agree to take part.
  • Must weigh at least 35 kg (about 77 lb).
  • Must follow the study’s sex and birth‑control (contraceptive) requirements.
  • Must be 18 years old or older, or the legal age to give consent in your country, when you sign the consent form.
  • Must have a diagnosis of stomach, gastroesophageal‑junction, or lower‑esophagus cancer that cannot be removed by surgery and is locally advanced or has spread, confirmed by a tissue test.
  • Must have cancer cells that test positive for the protein CLDN18.2.
  • Must have a PD‑L1 test result (called PD‑L1 CPS) that determines which group you belong to:
    • Group 1: PD‑L1 CPS ≥ 1 and the doctor decides you are eligible for immune‑checkpoint therapy.
    • Group 2: PD‑L1 CPS < 1 or the doctor decides you are not eligible for that therapy.
  • Must have an ECOG performance status of 0 or 1 (fully active or able to care for yourself) and not have gotten worse in the past two weeks.
  • Must be expected to live at least 12 weeks from the start of the study.
  • Must have at least one tumor lesion that can be measured or evaluated by the doctor using standard imaging rules (RECIST 1.1).
  • Must have blood and organ test results showing adequate organ and bone‑marrow function, meaning your liver, kidneys, blood‑forming cells, and other organs are working well enough for the study.

Who Cannot Join the Study?

  • Known HER2‑positive status – if tests show the cancer has the HER2 protein, you cannot join.
  • Uncontrolled diabetes or diabetic neuropathy (nerve damage from diabetes) that has not been managed in the past 3 months.
  • Active infections such as hepatitis A, uncontrolled hepatitis B (including high virus levels), chronic or active hepatitis C, or HIV that is not well‑controlled.
  • Partial or total DPD enzyme deficiency – a lack of the DPD enzyme that helps process certain chemotherapy drugs.
  • Significant or unstable gastric bleeding or untreated stomach ulcers.
  • Current or past autoimmune or inflammatory disorders that need treatment with steroids or other drugs that suppress the immune system, or if the doctor thinks participation is too risky.
  • CNS pathology – any disease of the brain or spinal cord.
  • Large amounts of fluid in the chest (pleural effusion) or abdomen (ascites) that need to be drained or require a catheter or shunt.
  • Need for parenteral nutrition (IV feeding) because a blockage prevents food from passing through the stomach or intestines.
  • Peripheral neuropathy (nerve damage in the hands or feet) at a moderate level or higher (CTCAE Grade 2 or above) when screened.
  • Ongoing side effects from previous cancer treatment (except hair loss) that have not improved to a mild level (Grade 1 or lower).
  • Any serious heart (cardiac) problems as described in the study protocol.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Orszagos Onkologiai Intezet Budapest Hungary
University Of Debrecen Debrecen Hungary
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Semmelweis University Budapest Hungary
Universidade De Santiago De Compostela Santiago De Compostela Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
University Of Pecs Pecs Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Cmblauwuu Uikrbthbscmrds Stmpprjbm Woluwe-Saint-Lambert Belgium
Ibczvcsw Pmaxvimwxcgsknq Cekwrh Cepecx Marseille France
Hvqcfriq Vdcw dguwwgrn Barcelona Spain
Initeiht Rbrzmizkn Pfn Lb Svgbzv Dxp Tuuvit Duie Amspfot Iigr Sjfksg Meldola Italy
Aicqifxrh Uwg Amsterdam The Netherlands
Eowwkkl Ulhgueefytxr Mxyqmuj Cajxrhy Rqdepdbxl (oecyptj Mhb Rotterdam The Netherlands
Siq Ebqkgkdhj Hgbwhqvt Tcelitc Tilburg The Netherlands
Gaqdudilddhvpjxps Vykpjmmxi Pfdu Aqycbz Effckixb Oflnfx Kkglzr Gyor Hungary
Nldpzfnq Ikblxghb Obgjihovp Ija Mjbzd Sdiuaxdqqghodoanauinsglngytd Idmxnxjn Bdjuiwvm Cracow Poland
Cxwejk Ljzd Bsapom Lyon France
Uomsgbxout Ow Afmwbcl Edegem Belgium
Uykynczcdaicrxbdmrtfa Ervnt Agx Essen Germany
Uvbigqhxyanj Mdclgfe Cxefgmb Gawnlqfyw Groningen The Netherlands
Heqvlgod Ukpqhgzvsvgif Mgfthav Dy Vtkoagbxsu Santander Spain
Uovfzctjnjuyeastqoovi Ajypohaq Augsburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
31.07.2026
France France
Not yet recruiting
31.07.2026
Germany Germany
Not yet recruiting
31.07.2026
Hungary Hungary
Not yet recruiting
31.07.2026
Italy Italy
Not yet recruiting
31.07.2026
Poland Poland
Not yet recruiting
31.07.2026
Spain Spain
Not yet recruiting
31.07.2026
The Netherlands The Netherlands
Not yet recruiting
31.07.2026

Trial locations

Oxaliplatin is a chemotherapy medicine that is given through an IV. It works by damaging the DNA of cancer cells, which helps stop their growth. In this study it is used as a standard‑of‑care comparison treatment.

Mycophenolate mofetil is a medicine that suppresses the immune system. It is taken as a capsule by mouth. In the trial it is part of the background therapy to help control the body’s immune response.

AZD0901 is an experimental drug that is given by IV. It is being tested in the trial to see if it can improve outcomes for patients with advanced gastric or esophageal cancer.

Infliximab is a biologic medication given as an IV infusion. It blocks a protein called TNF‑alpha that can cause inflammation. In this study it is included as part of the background treatment regimen.

Nivolumab is an immunotherapy drug that helps the body’s own immune cells recognize and attack cancer. It is administered by IV and is being evaluated as a potential new treatment option in the trial.

Folinic acid is a form of vitamin B9 given by IV. It is used to protect normal cells from the side effects of certain chemotherapy drugs. In this study it is used alongside other chemotherapy as a comparator.

Zolbetuximab is a monoclonal antibody that targets a protein called Claudin‑18.2 on cancer cells. It is given by IV infusion and serves as a comparator treatment in the trial.

Rilvegostomig is an investigational medication delivered by IV infusion. It is being tested both alone and in combination with other drugs to see if it can improve cancer control.

Capecitabine is an oral chemotherapy pill that the body changes into the active drug fluorouracil. It interferes with cancer cell DNA and is a key part of the experimental treatment regimen.

Fluorouracil is a chemotherapy drug given by IV infusion. It stops cancer cells from making DNA, slowing their growth. In this trial it is used as part of the standard‑of‑care comparison.

Sonesitatug vedotin is an antibody‑drug conjugate designed to target the Claudin‑18.2 protein on tumor cells. It delivers a cell‑killing agent directly to the cancer while sparing normal tissue. The study is testing this drug together with capecitabine, with or without rilvegostomig, to see if it works better than current standard treatments.

Gastric cancer – A cancer that starts in the lining of the stomach. It often begins as small abnormal cells that grow slowly, then become larger and invade deeper layers of the stomach wall. Over time it can spread to nearby lymph nodes and other organs.
Gastroesophageal junction adenocarcinoma – A cancer that forms at the point where the esophagus joins the stomach. It originates in gland‑like cells at this junction and can grow upward into the esophagus or downward into the stomach. The tumor may extend into surrounding tissues and lymph nodes as it progresses.
Esophageal cancer expressing Claudin‑18.2 – A type of esophageal cancer that carries the protein Claudin‑18.2 on its surface. The disease starts in the lining of the esophagus, grows deeper into the wall, and can spread locally and to distant sites. The Claudin‑18.2 expression is a distinct characteristic of the tumor cells.

Trial ID:
2024-519787-40-00
Protocol code:
D9803C00001
Trial Phase:
Therapeutic confirmatory (Phase III)

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