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Study of AFM24 and Atezolizumab for Patients with Advanced or Metastatic EGFR-expressing Cancers

Verified siteRegistered drugNo placebo

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Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
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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 certain types of advanced or metastatic cancers that express a protein called EGFR (Epidermal Growth Factor Receptor). These cancers have spread to other parts of the body and include types such as non-small cell lung cancer, gastric cancer, and liver cancer. The study is testing a combination of two treatments: AFM24 and Atezolizumab. AFM24 is a solution for injection or infusion, and Atezolizumab is a solution for infusion. Both are given through a vein, which is known as intravenous use.

The purpose of the study is to find out how safe and effective the combination of AFM24 and Atezolizumab is for treating these cancers. The study is divided into two phases. In the first phase, the goal is to determine the best dose of AFM24 when used with Atezolizumab. In the second phase, the study will look at how well the combination works in shrinking tumors. Some participants will receive a placebo, which is a substance with no active medication, to compare the effects.

Participants in the study will receive the treatments over a period of time, and their health will be monitored closely by the study team. The study will assess how the body processes the drugs and any side effects that may occur. The study aims to provide valuable information on the potential benefits of using AFM24 and Atezolizumab together for treating advanced cancers that express EGFR.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A pregnancy test is required for females of childbearing potential. Blood tests are performed to ensure adequate organ function and to check for any infections.
Step 2
Treatment initiation
The treatment involves two medications: AFM24 and atezolizumab. Both are administered as a solution for injection or infusion through a vein (intravenous).
The first phase, known as the dose escalation phase, aims to determine the safest and most effective dose of AFM24 when combined with atezolizumab.
Step 3
Dose escalation phase
During this phase, the focus is on identifying the maximum tolerated dose of AFM24. This involves monitoring for any side effects and adjusting the dose as necessary.
Patients are closely observed for any adverse reactions, and regular assessments are conducted to evaluate the body's response to the treatment.
Step 4
Expansion phase
Once the appropriate dose is determined, the study progresses to the expansion phase. This phase evaluates the effectiveness of the treatment in reducing tumor size.
Patients continue to receive the combination of AFM24 and atezolizumab, with regular monitoring to assess the treatment's impact on the cancer.
Step 5
Ongoing monitoring
Throughout the study, regular check-ups are scheduled to monitor health status and treatment effects. This includes imaging tests to track tumor response.
Blood samples are taken periodically to measure drug levels and check for any immune responses against the medications.
Step 6
Completion and follow-up
Upon completion of the treatment period, a final assessment is conducted to evaluate overall health and treatment outcomes.
Follow-up visits may be scheduled to monitor long-term effects and gather additional data on the treatment's efficacy.

Who can join the trial?

11 criteria

You must voluntarily agree to participate and sign a written consent form before any study-related procedures begin.
You must be at least 18 years old on the day you sign the consent form.
You must have proof that your cancer has gotten worse during or after your last treatment.
You must have certain types of advanced or metastatic cancers that show a protein called **EGFR**. This includes specific types of lung, stomach, liver, bile duct, or pancreatic cancers.
You must be able to perform daily activities with little or no assistance, as measured by the **ECOG Performance Status** of 0 or 1.
Your organs must be working well, which includes having enough blood cells, proper liver and kidney function, and normal blood clotting levels.
Your levels of potassium, calcium, magnesium, and phosphate in the blood must be normal or only slightly abnormal and without symptoms.
If you have hepatitis B, the virus level in your blood must be low. If you had hepatitis C and it is cured, you can participate.
You must have cancer that can be measured or evaluated using specific medical guidelines called **RECIST v1.1**.
If you are a woman who can have children, you must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 5 months after the last dose of the study drug.
If you are a man with a female partner who can have children, you must agree to use effective birth control during the study and for 5 months after the last dose of the study drug.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer that does not express **EGFR**. **EGFR** is a protein that can be found on the surface of some cancer cells.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications or their ingredients.
Patients who have a history of certain medical conditions that the study team considers unsuitable for participation.

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Verified sites

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Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
Not recruiting
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Hospital Universitario De Navarra
Pamplona, Spain
Verified
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcon, Spain

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Investigated drugs

AFM24
is an experimental medication being studied for its potential to treat certain types of advanced or metastatic cancers that express a protein called EGFR. It is being tested to see how safe and tolerable it is for patients, as well as how it behaves in the body and its effectiveness in fighting cancer.
Atezolizumab
is a medication that helps the immune system fight cancer. It works by blocking a protein that can stop the immune system from attacking cancer cells. In this trial, it is being used in combination with AFM24 to see if the two medications together can improve treatment outcomes for patients with specific types of cancer.

What is already known about the treatment

AFM24
AFM24 is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced or metastatic cancers that express the EGFR protein. It is in the early stages of research, specifically in Phase 1/2a trials, to assess its safety, tolerability, and effectiveness. The main therapeutic indication for AFM24 is in combination with atezolizumab to target specific cancer types. At the molecular level, AFM24 works by engaging the immune system to attack cancer cells that express the EGFR protein. It is classified as an immunotherapy agent.
Atezolizumab
Atezolizumab is administered intravenously and is an established medication used in the treatment of various cancers, including those expressing the EGFR protein. It is currently being evaluated in combination with AFM24 in clinical trials to enhance its effectiveness against advanced or metastatic cancers. The main therapeutic indication is to boost the immune response against cancer cells. Atezolizumab functions by inhibiting the PD-L1 protein, which helps cancer cells evade the immune system. It is classified as a monoclonal antibody and an immune checkpoint inhibitor.

Investigated diseases

Advanced/Metastatic EGFR-expressing Cancers – These are cancers that have spread beyond their original site and express the epidermal growth factor receptor (EGFR). EGFR is a protein on the surface of cells that, when mutated or overexpressed, can promote the growth of cancer cells. As the disease progresses, it can invade nearby tissues and spread to distant parts of the body, a process known as metastasis. This type of cancer can affect various organs, including the lungs, colon, and head and neck regions. The progression of the disease often leads to increased symptoms and complications as the cancer cells continue to grow and spread. Understanding the role of EGFR in these cancers is crucial for developing targeted therapies.