European Lung Foundation

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 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)