A Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients with Unresectable or Metastatic B7-H3-Expressing Neoplasms and Neoplasms whose Vasculature Expresses B7-H3
Sponsor: |
MacroGenetics, Inc. |
Enrolling: |
Male Patients Only |
IRB Number: |
AAAR6359 |
U.S. Govt. ID: |
NCT02628535 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
We are doing this study to test a drug called MGD009. MGD009 is like an antibody, which is a protein in your blood that helps get rid of germs in your body. MGD009 is made to attach to cancer cells and to T-cells, which are a part of your immune system. Certain T cells have the ability to kill other cells, including cancer cells. By attaching to cancer cells and Tcells, MGD009 may help your immune system kill the cancer cells. Though MGD009 has been studied in animals, this study will be the first time MGD009 will be given to humans to be tested as a possible treatment for cancer. The purpose of the study is to find the answers to these research questions: What are the side effects of GD009? At what dose levels are side effects of MGD009 observed? What is the maximum dose of MGD009 that can be given to patients without serious side effects? How long does MGD009 stay in your blood? Can MGD009 treatment cause some tumors to shrink or grow more slowly?
This study is closed
Investigator
Charles Drake, MD
Are you 18 years of age or older? |
Yes |
No |
Do you have a life expectancy of greater than or equal to 12 weeks? |
Yes |
No |