European Lung Foundation

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This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

MGD019 DART® Protein in Unresectable/Metastatic Cancer.

The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of MGD019 in patients with Squamous Cell Non-Small Cell Lung Cancer.

Trial ID: NCT03761017

Trial Details

When the body’s immune system detects something harmful, it produces antibodies. Antibodies are proteins that fight infection. Specific types of antibodies can be made in the laboratory and can be used to affect the function of cells in the immune system that can attack cancer cells. Cancer cells have been shown to have the ability to hide from the body’s immune system. PD-1 and CTLA-4 are two proteins on the T cells, a type of cell in the immune system that can attack cancer cells. The cancer cells interact with PD-1 and CTLA-4 on the T cells, which decreases their ability to attack cancer cells. MGD019 attaches to both PD-1 and CTLA-4 to block this process and is being studied to evaluate its ability to allow the T cells to recognize and kill cancer cells.

Four PD-1 binding antibody drugs have been approved by the US FDA (United States - Food and Drug Administration) to treat patients with advanced cancer types including melanoma, non-small cell lung cancer, Hodgkin’s lymphoma, squamous cell cancer of the head and neck, renal cell carcinoma (kidney cancer) and urothelial cancers (bladder cancer). Additionally, one of these PD-1 binding antibody drugs has been approved in combination with a CTLA-4 binding antibody drug in certain patient populations with melanoma, renal cell carcinoma, and colorectal cancer.

Although MGD019 has been studied in animals, this study is the first time MGD019 will be given to humans to be tested as a possible treatment for cancer.

Estimated Enrollment

287 Participants

Phase

Phase 1

Eligibility Criteria

Participants must:

Have been diagnosed with non-small cell lung cancer (NSCLC)
Be at least 18 years old
Have progressed during or following treatment with chemotherapy for advanced disease.

Participants must not:

Be pregnant or breastfeeding
Have symptoms of Central Nervous System (CNS) metastases. Patients with history of prior CNS metastasis must have been treated and no longer have symptoms.
Have a history of trauma or major surgical procedure within 4 weeks prior to initiation of study drug administration
Have a history radiation therapy within 2 weeks prior to initiation of study drug administration
Have been treated with systemic steroids (≥ 10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to initiation of study drug administration.
Have a known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
Have a known history of hepatitis B or hepatitis C infection.
Have active confirmed or presumed COVID-19 infection. Patients may be considered eligible after a resolved COVID-19 infection.

What Will Happen in This Study

What’s Involved

In this study, MGD019 will be given in “cycles”. Each cycle will last for 12 weeks. Participants will receive MGD019 once every 3 weeks for up to 9 cycles of the study. MGD019 will be given to you by IV administration.

Periodically, participant will have a CT scan (Computed Tomography) or an MRI (Magnetic Resonance Imaging) to check the effect of treatment on your cancer. A CT scan is a picture of your body using radiation. An MRI scan is a picture of your body using magnets.

You will need to travel to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

You will not be paid for your time. However, all study related services are provided at no cost. The Sponsor may provide reimbursement for your transportation and may arrange transportation to the study site. The study site will review all these details with you. Also, you do not have to pay anything to be in the study. All study related services are provided at no cost.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new treatments. The trial team will share more details with you if you are eligible for this trial and will give your volunteer consent to participate before you participate.

Can I quit the trial at any time?

Participation in this study is voluntary and you have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Name, surname and initials
Contact details:
- Residence address
- Correspondence address
- Telephone number, address , telephone number, health insurance number where applicable.
Sex, age
Date of Birth
ethnic and racial background.
Health condition data including history of disease, including test results, biological samples
Participant’s code

Who has access to your personal information?

All your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information, as indicated above. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information.

Where can I learn more about this research study?

You can visit the following website https://reec.aemps.es to learn more.