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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
Med Polonia Sp. z o.o.	Poznan	Poland
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Nmmrrrnk Ifnqotcr Omepyzuzz Idv Moxqc Sieeohcpmjeigyxhylwhkzaavcmh Ixodktww Bxpmnudq	Cracow	Poland
Happibly Vamn dlbeteun	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	12.01.2022
Spain	Not recruiting	12.01.2022

Trial locations

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.

Investigated diseases:

Neoplasm malignant

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.

Trial ID:

2024-511999-32-00

Protocol code:

AFM24-102

NCT ID:

NCT05109442

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?