Recruiting

Study of AZD5863 for Adults with Advanced or Metastatic Solid Tumors

Verified siteRegistered drugNo placebo

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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 a new treatment for people with advanced or metastatic solid tumors. These are types of cancer that have spread from their original location to other parts of the body. The treatment being tested is called AZD5863, which is a special type of medicine known as a bispecific antibody. This means it is designed to target two specific proteins, Claudin 18.2 and CD3, which are found in some cancer cells. The study aims to understand how safe and tolerable this treatment is for patients, as well as to see how well it works against the cancer.

The study will be conducted in two main parts. The first part, called dose escalation, will involve gradually increasing the dose of AZD5863 to find the most suitable amount that can be given safely. The second part, known as dose expansion, will further explore the safety and potential benefits of the treatment at the identified dose. Participants will receive AZD5863 either on its own or in combination with other treatments. The medicine can be given through an injection under the skin or directly into a vein.

Throughout the study, researchers will closely monitor participants for any side effects and changes in their health. They will also measure how the cancer responds to the treatment. The goal is to gather important information that could lead to new treatment options for people with these types of cancer. This study is expected to continue until the end of 2026.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and previous treatments.
A positive expression of CLDN18.2 in tumor cells is required, along with adequate organ and bone marrow function.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current health status, including a review of medical history and a physical examination.
Baseline measurements are taken, including vital signs and laboratory tests.
Step 3
Dose escalation phase
The dose escalation phase involves receiving the medication AZD5863 to determine the safest and most effective dose.
The medication is administered either intravenously or subcutaneously, depending on the specific protocol.
Step 4
Monitoring and evaluation
Regular monitoring is conducted to assess the body's response to the medication, including any side effects.
Frequent evaluations include laboratory tests and imaging studies to track the progress of the treatment.
Step 5
Dose expansion phase
In the dose expansion phase, the treatment continues with the established dose to further evaluate its effectiveness.
The focus is on understanding the medication's impact on tumor activity and overall health.
Step 6
Follow-up
After completing the treatment phases, follow-up visits are scheduled to monitor long-term effects and overall health.
These visits may include additional tests and assessments to ensure continued well-being.

Who can join the trial?

9 criteria

Must be **18 years or older** at the time of signing the consent form.
Must have a confirmed diagnosis of **adenocarcinoma**, which is a type of cancer, in the stomach, gastro-esophageal junction, esophagus, or pancreas.
Must have at least one **measurable lesion**, which means a tumor that can be measured, according to specific guidelines called RECIST v1.1.
Must show **positive CLDN18.2 expression** in tumor cells, which is a specific protein found in the cancer cells, as determined by a special test called central IHC.
Must have an **ECOG Performance Status** of 0-1 at screening, which is a scale used to assess how well a person can perform daily activities.
Must have a **predicted life expectancy** of at least 12 weeks.
Must have **adequate organ and bone marrow function**, which means the organs and bone marrow are working well enough, as measured within 28 days before the first dose.
Must use **contraception** if required by local regulations, which means using methods to prevent pregnancy.
Must have received at least one prior line of **systemic therapy**, which is treatment that travels through the bloodstream, in the advanced or metastatic setting.

Who cannot join the trial?

4 criteria

Patients who do not have **advanced or metastatic solid tumors**. This means the cancer has not spread to other parts of the body.
Patients whose tumors do not show **CLDN18.2 expression**. This is a specific protein found in some cancer cells.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population that the study does not include.

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Institut Gustave Roussy
Verified
Villejuif, France

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Investigated drugs

AZD5863 is a special type of medication known as a bispecific antibody. It is designed to help the body's immune system target and attack cancer cells. This medication works by connecting two different targets: Claudin 18.2, which is found on certain cancer cells, and CD3, which is present on T cells, a type of immune cell. By linking these two targets, AZD5863 helps the immune system recognize and destroy cancer cells more effectively. This trial is exploring the safety and effectiveness of AZD5863 in adults with advanced or metastatic solid tumors that express Claudin 18.2.

What is already known about the treatment

AZD5863 – This medication is administered as an intravenous infusion and is currently being studied in clinical trials for its potential use in treating advanced or metastatic solid tumors. It is a bispecific antibody that targets Claudin 18.2 and CD3, aiming to engage T cells to attack cancer cells. The main therapeutic indication is for tumors expressing Claudin 18.2. AZD5863 works by binding to both the cancer cell marker Claudin 18.2 and the CD3 receptor on T cells, facilitating the immune system's ability to target and destroy cancer cells. It is classified pharmacologically as an immunotherapy agent, specifically a bispecific T cell engager.

Investigated diseases

Advanced or Metastatic Solid Tumors – These are cancers that originate in solid organs or tissues and have progressed to an advanced stage, often spreading to other parts of the body. The term "advanced" typically refers to cancer that is locally advanced, meaning it has grown significantly but may not have spread to distant sites. "Metastatic" indicates that the cancer cells have spread from the original tumor site to other parts of the body, forming new tumors. This progression can occur through the bloodstream or lymphatic system. The behavior and growth rate of these tumors can vary widely depending on the type of cancer and its location. As the disease progresses, it can affect the function of the organs involved, leading to various symptoms.