Study of AZD5863 for Adults with Advanced or Metastatic Solid Tumors

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Uvzdjgxawwvt Mwcwptg Czjoxhm Gvwielziq	Groningen	The Netherlands
Aozwhcens Uoi	Amsterdam	The Netherlands
Errlnar Uercufozcqic Maybogh Cbcywbi Roqsstach (qidzgxy Mmm	Rotterdam	The Netherlands
Ieiobxcu Pkgdgnnwxgplrqf Cafnzv Cscdif	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.10.2023
The Netherlands	Recruiting	15.10.2023

Trial locations

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.

Investigated diseases:

Neoplasm

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.

Trial ID:

2023-504139-42-00

Protocol code:

D9750C00001

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of AZD5863 for Adults with Advanced or Metastatic Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?