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

Verified siteInvestigational

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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 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.

The research process

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

Step 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
Step 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
Step 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
Step 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 trial?

10 criteria

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
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Must have a confirmed diagnosis of advanced or spreading (metastatic):
- Pancreatic cancer (PDAC), or
- Stomach or stomach-esophagus junction cancer, or
- Bile duct cancer
- 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 trial?

16 criteria

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
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Significant heart problems, including:
- Heart attack within the last 6 months
- Unstable angina (chest pain)
- Heart failure
- close
  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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Klinikum der Universitaet Muenchen AöR
Munich, Germany
Verified
Rheinische Friedrich-Wilhelms-Universitaet Bonn
Bonn, Germany

Trial locations

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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.

AZD4360

What is already known about the treatment

AZD4360 – An investigational drug being studied in clinical trials for the treatment of advanced solid tumors, particularly focusing on gastric cancer, gastroesophageal junction cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma. This medication specifically targets tumors expressing CLDN18.2, a protein marker found in certain types of cancer cells. The drug is currently being evaluated in Phase I/II clinical trials to determine its safety profile, how the body processes the medication (pharmacokinetics), and its effectiveness in treating these types of cancers. The exact method of administration is still under investigation as part of the ongoing clinical trials, with researchers working to establish the optimal dosing strategy and safety parameters.

Investigated diseases

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.