Study of AZD4360 safety and effectiveness in adults with advanced solid tumors including gastric, gastroesophageal junction, biliary tract cancer and pancreatic cancer

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What is this study about?

This study focuses on patients with advanced solid tumors, specifically gastric cancer, gastroesophageal junction cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma. These are types of cancer that have spread or cannot be removed by surgery. The study will test a new medication called AZD4360, which is an antibody drug conjugate given through an intravenous infusion (delivered directly into a vein).

The purpose of this research is to understand how safe AZD4360 is and how well it works in treating these types of cancer. The study will also examine how the medication moves through the body over time. The medication will be given to patients whose cancer has a specific characteristic called CLDN18.2 expression and who have already received at least one previous treatment for their cancer.

This is a combined Phase 1 and Phase 2 study, which means it will first determine the safest dose of the medication and then test how effective it is at treating these cancers. During the study, participants will receive AZD4360 and undergo various medical assessments to monitor their health and the medication’s effects. The treatment will continue as long as patients are benefiting from it and not experiencing unacceptable side effects.

1 Initial screening and qualification

Your medical condition must be confirmed as one of the following: advanced or metastatic pancreatic ductal adenocarcinoma, gastric cancer, gastroesophageal junction cancer, or biliary tract cancer

Your tumor must test positive for CLDN18.2 expression

You must have received at least one previous treatment for advanced/metastatic disease

Your overall physical condition will be evaluated using the Eastern Cooperative Oncology Group scale (rating of 0-1 required)

Your organ function and blood test results must meet specific requirements

You must be at least 18 years old

2 Treatment administration

You will receive AZD4360 through an intravenous infusion (delivered directly into your vein)

The medication comes as a powder that will be mixed into a solution before administration

The dose you receive may vary depending on which study group you are assigned to

3 Monitoring and evaluations

Regular blood samples will be taken to measure how the medication moves through your body

Your tumor response will be evaluated using imaging scans

Your vital signs, laboratory values, and heart activity (ECG) will be monitored regularly

Any side effects will be recorded and assessed

The study team will check for antibodies your body might develop against the medication

4 Study duration

The study is expected to run from November 2025 to March 2027

Your participation length will depend on how your body responds to the treatment

You must have a life expectancy of at least 12 weeks to participate in the study

Who Can Join the Study?

  • Must be 18 years or older when signing the consent form
  • Must have a good level of physical functioning (ECOG performance status of 0-1), with no worsening in the 2 weeks before starting treatment. ECOG status measures how well a person can perform daily activities
  • Must have a life expectancy of at least 12 weeks as determined by the doctor
  • Must have normal organ function and adequate blood cell counts as specified in the study protocol
  • Must use appropriate contraception methods according to local regulations
  • Must have a confirmed diagnosis of advanced or spreading (metastatic):
    • Pancreatic cancer (PDAC), or
    • Stomach or stomach-esophagus junction cancer, or
    • Bile duct cancer

    with positive CLDN18.2 expression (a specific protein marker)

  • Must have received at least one previous treatment for advanced or spreading cancer
  • Must have at least one tumor that can be measured using standard imaging techniques (RECIST v1.1)

Who Cannot Join the Study?

  • Prior treatment with a CLDN18.2 targeted therapy (a specific type of cancer treatment)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Uncontrolled high blood pressure
  • Major surgery within 4 weeks before starting the study treatment
  • History of another cancer in the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Significant heart problems, including:
    • Heart attack within the last 6 months
    • Unstable angina (chest pain)
    • Heart failure
  • Active or chronic infections, including:
    • Hepatitis B
    • Hepatitis C
    • HIV
  • Severe liver problems
  • Severe kidney problems
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.11.2025

Trial locations

Investigated drugs:

AZD4360 is an investigational medication being studied for the treatment of advanced solid tumors, specifically in patients whose tumors express CLDN18.2. This is a new drug that is being tested to understand how safe it is and how well it works in treating cancer. The medication targets specific proteins found in certain types of tumors and is being evaluated in patients who have already received previous cancer treatments.

Gastric Cancer – A disease that develops in the inner lining of the stomach, where normal cells begin to grow abnormally and form tumors. The cancer typically develops slowly over many years, starting with changes in the stomach’s inner lining. It can spread through the different layers of the stomach and eventually to other parts of the body.

Gastroesophageal Junction Cancer – A cancer that forms in the area where the esophagus joins the stomach. This type of cancer begins in the cells of the tissue at this junction point and can grow in either direction, affecting both the esophagus and stomach. The disease typically develops gradually from changes in the cells at this junction.

Biliary Tract Cancer – A cancer that develops in the bile ducts, which are tubes that connect the liver, gallbladder, and small intestine. The disease begins in the cells lining these ducts and can occur in different parts of the biliary system. As it progresses, it can affect the normal flow of bile and spread to nearby tissues.

Pancreatic Ductal Adenocarcinoma – A cancer that starts in the cells lining the ducts of the pancreas, which carry digestive enzymes. It begins when normal cells in these ducts start to grow uncontrollably and form tumors. The disease can affect the pancreas’s ability to produce digestive enzymes and hormones.

Trial ID:
2024-518281-27-00
Protocol code:
D8930C00001
NCT ID:
NCT06921928
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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